Friday Factoids

Congress

Friday Factoids

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • Healthcare Dive informs us
    • “The Senate continued to probe the impact of private equity on healthcare delivery this week, launching both an inquiry into PE’s emergency department management practices and holding a subcommittee field hearing on “corporate greed” and PE’s impact on patient care.
    • “The field hearing and request for information come as private equity has increased its investment in healthcare. As of January, more than a quarter of the nation’s rural hospitals and 460 total hospitals in the U.S. were owned by private equity firms, according to a tracker produced by nonprofit watchdog, the Private Equity Stakeholder Project. 
    • “PE-backed physician staffing groups operate nearly one-third of emergency departments across the country, according to letters sent Monday to some of the nation’s largest private equity companies by Sen. Gary Peters, D-Mich., and chair of the Senate’s Homeland Security Committee. * * *
    • “PE firms acquire assets and then seek to sell them for profit, typically within a three- to five-year time frame. The investors may also have limited direct knowledge of healthcare, and the funds are subject to fewer regulations than public companies, according to a 2023 report from the CommonWealth Fund. As a result, the firms tend to have fewer patient-centric guardrails in place compared to traditional healthcare owners and investors.”
  • Fierce Healthcare tells us,
    • “Centers for Medicare & Medicaid Services finalized a host of actions ranging from broker compensation, health equity, mental health, supplemental benefits and biosimiliars, in the Contract Year 2025 Medicare Advantage and Part D final rule Thursday night.
    • “Technical experts and industry execs warned the changes will be consequential for MA plans.
    • “Yesterday’s 2025 Final Rule was one of the more impactful that I can recall in my two-plus decades in the industry,” said Sean Libby, president at BeneLynk. “It is clear that MA plans need a roadmap for health related social needs and health equity.”
    • “It is difficult to put words to the extent and impact of changes codified today,” saidMelissa Newton Smith, senior advisor for Oliver Wyman. “Every MA leadership team needs to be thoughtfully redesigning your stars and quality approach in order to earn quality bonus payments in 2025.”
    • “The primary winners are behavioral health providers, namely Arcadia Healthcare and Universal Health Systems,” said global strategy firm Capstone in a new analysis.
  • Per BioPharma Dive,
    • “The Food and Drug Administration has cleared Bristol Myers Squibb and 2seventy Bio’s multiple myeloma cell therapy for earlier use treating the blood cancer, approving the CAR-T medicine for patients who have previously received at least two previous drug regimens.
    • “The OK comes three weeks after a panel of FDA advisers agreed the benefit of earlier treatment outweighed the risks, including a concern raised by agency reviewers over data indicating an elevated risk of death among treated study participants in the first year of the companies’ main trial.
    • “Overall, trial results showed the CAR-T therapy, Abecma, reduced the risk of disease progression or death by about half, compared to standard regimens. Bristol Myers cited patient crossover from the control arm to treatment as confounding survival data, while the advisory panel noted complications with the “bridging” therapy used prior to CAR-T treatment.”
  • Fierce BioTech lets us know,
    • “As new cancer vaccines—led by Moderna and Merck’s mRNA-4157—near pivotal trial readouts, the FDA’s vaccines czar Peter Marks, M.D., Ph.D., said the agency is ready to review the shots despite AI-related unknowns.
    • “We are ready to review—we’re open for business,” Marks, director of the FDA’s Center for Biologics Evaluation and Research, said of cancer vaccines at the 2024 World Vaccine Congress (WVC).
    • “We have therapeutic cancer vaccines coming in; I think we would review them very much like we could review potentially a CAR-T cell or other therapeutic products,” Marks said.”
  • Per an FDA press release,
    • “Today, the FDA issued an emergency use authorization (EUA) for CorDx, Inc.’s CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test, a single use test intended to detect and differentiate influenza A and B (commonly known as flu) and SARS-CoV-2 (the virus that causes COVID-19), in individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first five days of symptom onset when tested at least twice over three days with at least 48 hours between tests. Validation data to support the EUA of this test was gathered through the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP), established as a collaboration between the FDA and the NIH. The test can be used for people aged 14 years or older with a self-collected nasal swab specimens and aged 2 years or older when an adult collects the nasal swab specimens.”
  • The Washington Post reports,
    • “A group of public health experts and scientists is calling on the Food and Drug Administration to rescind its controversial approval of a DNA test that promises to predict genetic risk of opioid addiction.
    • “In a letter sent to the agency on Thursday, 31 experts in genetics, addiction, psychiatry and medical-device regulation called the approval of AvertD a mistake that relied on faulty science and puts patients at risk. The group sent a separate letter to the Centers for Medicare and Medicaid Services urging the agency, which oversees government health insurance programs, to deny coverage for the prescription-only test.
    • “The Washington Post last month highlighted concerns about the test’sreliability and the unintended consequences of false results. The letters said a negative test could give patients a false sense of security, or lead doctors to “refrain from prescribing opioids to patients who test positive, even in situations where opioids are beneficial.”
  • MedTech Dive lets us know,
    • “Smiths Medical is recalling more than 2,900 emergency ventilators in the U.S. after receiving reports of a fault linked to eight serious injuries, the Food and Drug Administration said Thursday.
    • “The fault can cause patients to receive the wrong amount of ventilation or too little oxygen, as well as a complete or partial airway obstruction. The FDA categorized the event as a Class I recall because of the risk of serious injury or death.
    • “Smiths Medical, which has faced a series of regulatory actions in recent years, told customers to continue using the Pneupac Parapac Plus 300 and 310 Ventilator Kits but to take precautions.”

From the public health and medical research front,

  • The Centers for Disease Control announced today,
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare remains elevated nationally but is decreasing across many areas of the country. This week, 6 jurisdictions experienced high activity compared to 10 jurisdictions experiencing high activity the previous week. No jurisdictions experienced very high activity. 
    • “Nationally, emergency department visits with diagnosed COVID-19, influenza, and RSV are decreasing.   
    • “Nationally, COVID-19, influenza, and RSV test positivity decreased compared to the previous week. 
    • “Nationally, the COVID-19 wastewater viral activity level, which reflects both symptomatic and asymptomatic infections, remains low.
  • STAT News reports,
    • “The Centers for Disease Control and Prevention urged medical practitioners on Friday to be on the lookout for people who might have contracted H5N1 bird flu from cows. The agency also urged state health departments to rapidly assess any suspected human cases, and recommended that dairy farms with confirmed or suspected outbreaks require workers to use personal protective equipment.
    • “The recommendations were outlined in a health alert network advisory, or HAN in CDC parlance. The advisory is in response to the outbreak of H5N1 avian influenza in at least 16 dairy herds in six states across the country, which has led to at least one human infection so far.
    • “Health care providers should ask themselves “Could this be an H5N1 infection?” if they are faced with a patient with what CDC called a relevant exposure history — for instance, someone who works with dairy cows or lives with someone who works with dairy cows.”
  • Medscape notes,
    • “Cognitive assessments administered via a smartphone app are a reliable and valid way to detect frontotemporal dementia (FTD) in high-risk individuals, new research showed.
    • “Cognitive tests administered remotely on the phone “showed similar findings as our gold standard in-clinic cognitive tests and brain imaging,” study investigator Adam M. Staffaroni, PhD, with the Memory and Aging Center, University of California San Francisco, told Medscape Medical News.
    • “We also provided evidence that these assessments may be useful for detecting early symptoms of the disease at a level that is on par, or perhaps slightly better, than our gold standard in-person tests,” Staffaroni said.
    • “The study was published online on April 1 in JAMA Network Open.

From the U.S. healthcare business front,

  • CNBC reports,
    • “CVS Health on Thursday said its drug plans will cover the first over-the-counter birth control pill in the U.S. at no cost for many health plan sponsors, a decision that could open the door for more people to prevent unintended pregnancies without a prescription. 
    • “The company’s pharmacy benefit manager, CVS Caremark, said the pill will be added to its preventive services oral contraceptives list and will be covered at zero cost for many sponsors. The drug, known as Opill from Perrigo, was available at pharmacies starting April 1, according to a pharmacy update from CVS Caremark dated last week and viewed by CNBC.
    • “Pharmacy benefit managers, or PBMs, maintain lists of drugs covered by health insurance plans and negotiate drug discounts with manufacturers. At most stores, Opill has a retail price of $19.99 for a one-month supply and $49.99 for a three-month supply.” 
    • FEHBlog note — Smart move, CVS Health.
  • The President of the Institute for Clinical and Economic Review comments,
    • “Yesterday Amylyx announced it would remove Relyvrio, a treatment for amyotrophic lateral sclerosis (ALS), from the market. The drug was originally approved in 2022 based on a small phase II trial, well ahead of the conclusion of its phase III trial. The results of that phase III trial were reported last month and unfortunately, the therapy failed to provide any benefit to patients. Historically, a failed trial following FDA approval has not resulted in an automatic revocation of FDA approval or withdrawal of the drug from the market, and post-marketing trial requirements are not consistently used to assess the regulatory status of all approved products. Despite this hole in regulation, Amylyx made the responsible decision to discontinue this drug, and is being rightly lauded for the choice. 
    • “Of course, everyone hopes that treatments approved early with limited evidence will prove effective. But when they don’t, this is how it is supposed to play out: patients get early access to a potentially promising treatment, and then when all the data come in and the benefits fall short, the manufacturer removes the drug from the market. What’s missing from this story though is price: since 2022, the health system paid a steep price for a drug with no proven benefit to patients. When ICER reviewed Relyvrio (prior to FDA approval), we recommended that the manufacturer consider setting the launch price, “close to the cost of production until the benefits of treatment can be adequately evaluated.” Amylyx priced the drug at $158,000 per year, far beyond ICER’s recommended price of $9,100 to $30,700 per year, a price range based on the benefits shown in the small phase II trial. The fact is, that when our health care system allows pricing of treatments far above any reasonable alignment with the benefits they have demonstrated for patients, we do real harm to unseen people in the health care system. Costs increase for everyone without making anyone healthier. And as costs increase, more people forgo care or drop their health insurance all together. 
    • “Even though the story played out as planned this time, the system can be improved to protect all patients and ensure affordability for everyone.”
  • BioPharma Dive relates,
    • “Johnson & Johnson has agreed to acquire Shockwave Medical for approximately $13.1 billion, the companies announced Friday morning. The deal values Shockwave at $335 per share.
    • “J&J said in a statement that Shockwave will expand its “cardiovascular portfolio into two of the highest-growth, innovation-oriented segments of cardiovascular intervention – coronary artery disease and peripheral artery disease.”
    • “Both companies’ boards have approved the transaction, and J&J expects the deal to close in mid-2024.”
  • and
    • “Boehringer Ingelheim is laying off staff in response to sluggish adoption of its Humira biosimilar Cyltezo, a company spokesperson confirmed to BioPharma Dive. Stat first reported the news Thursday.
    • “The German company said it will trim its customer-facing teams in favor of a hybrid in-person and virtual sales model by June 30, but didn’t specify how many jobs are affected. Pharmacy benefit managers, or PBMs, have kept Humira on their coverage lists, resulting in cheaper copycats like Cyltezo falling below their “anticipated potential,” the spokesperson said.
      • “Humira, a blockbuster immune disease drug sold by AbbVie, began facing biosimilar competition in the U.S. last year. Launched in July,Cyltezo is one of more than half a dozen Humira biosimilars now available, but holds an advantage due to its “interchangeable” designation, which allows pharmacists to substitute it for Humira.”
  • Per Healthcare Dive,
    • “Teladoc Health’s long-time chief executive officer Jason Gorevic is leaving the virtual care giant effective immediately, the company said Friday.
    • “Gorevic has been CEO since 2009 and oversaw a period of exponential growth for Teladoc during the COVID-19 telehealth boom. However, he’s departing after the telehealth company struggled to sustain that momentum as the pandemic waned. Teladoc’s stock has sunk significantly since early 2021, and recently hit an eight-year low.
    • “The leadership change is probably coming at the right time, as the company focuses on a longer-term profit growth strategy, Leerink Partners analysts Michael Cherny, Daniel Clark and Ahmed Muhammad wrote in a Friday note.”
  • and
    • “Telehealth company Amwell is in trouble with the New York Stock Exchange for its stock price trading below the minimum standard for listing.
    • “Amwell was a high-flying stock during COVID-19, as the value of telehealth companies soared due to demand for virtually provided medical care. The price of Amwell’s shares peaked at $42.80 in January 2021. However, for the past 30 days, Amwell’s shares have closed at less than $1, sparking a warning notice from the NYSE.
    • “NYSE rules give Amwell six months to regain compliance. In a Thursday release, Amwell said it plans to effect a reverse stock split — when existing shares are consolidated into fewer but more valuable shares, boosting a company’s stock price. Amwell’s board and shareholders will vote on the proposal at an annual meeting later this year.” 
  • In this regard, the FEHBlog heard a health system executive comment at the ABA’s Health Law Section’s Emerging Healthcare Law Issues conference —
    • While the amount of telehealth services has returned a little higher than pre-pandemic 2019 levels, telehealth vendors that hang on will be a lifesaver in the looming physician shortage crisis.

Weekend update

David Ermer–Congress, Medical / Rx research, OPM, U.S. Healthcare–

Happy Easter! Yesterday, the FEHBlog read about a 1964 Italian film called the Gospel According to St. Matthew. The FEHBlog found and watched the film on the Concierge Channel following two UConn basketball victories. The film is available on YouTube.

From Washington, DC,

  • Congress continues it break from Capitol Hill this week.
  • Last Wednesday, OPM’s PBM pharmacy benefits panel at the FEHB carrier conference featured a New Jersey attorney who was warning that plan sponsors can be held liable for PBM contracting mismanagement, pointing to the Lewandowski v. Johnson & Johnson case.   Here is a link to the defense counsel’s letter to the federal district court in New Jersey describing Johnson & Johnson’s strong (in my opinion) defenses in that ERISA case and a link to a related 1st Circuit ERISA opinion from earlier this year.  In any case, as the FEHBlog pointed out at the conference, FEHB plans are exempt from ERISA as governmental plans.

From the public health and medical research front,

  • The Washington Post reports,
    • “More than three-quarters of sudden infant deaths involved multiple unsafe sleep practices, including co-sleeping, a recent analysis suggests.
    • “A study published in the journal Pediatrics looked at 7,595 sudden infant death cases in a Centers for Disease Control and Prevention registry between 2011 and 2020. The majority of deaths occurred in babies less than 3 months old.
    • “The statistics revealed that 59.5 percent of the infants who died suddenly were sharing a sleep surface at the time of death, and 75.9 percent were in an adult bed when they died. Though some demographic factors such as sex and length of gestation were not clinically significant, the researchers found that the babies sharing a sleep surface were more likely to be Black and publicly insured than those who didn’t share sleep surfaces. Soft bedding was common among all the infants who died, and 76 percent of the cases involved multiple unsafe practices.
    • “The analysis mirrors known risk factors for sudden infant death. Current recommendations direct parents and other caretakers to provide infants with firm, flat, level sleep surfaces that contain nothing but a fitted sheet. Though room sharing reduces the risk of sudden infant death, CDC officials discourage parents from sharing a sleep surface with their child.”
  • Fortune Well tells us,
    • “Oral health isn’t one of the most exciting self-care practices—but it’s an important one. What’s going on in your mouth is a strong indicator of your overall well-being. So, brushing and flossing every day isn’t just a bid for your dentist’s approval, it’s a win for your overall health. 
    • “Experts say there’s one more way to look after your teeth and gums: rinsing your mouth with water after you eat. * * *
    • “Every time you eat, your saliva breaks food down for digestion which will create an acid byproduct,” explains Lilya Horowitz, DDS, of Domino Dental in Brooklyn, New York. “This leads to more biofilm and plaque buildup, so rinsing with a neutral or basic water can help lower the pH in the mouth.” In an acidic environment or an environment below 4.5 pH, the enamel of the teeth will start to break down.”
  • MedPage Today lets us know,
    • Starting medication for alcohol use disorder (MAUD) at hospital discharge reduced readmission risk, a cohort study suggested.
    • Of nearly 10,000 alcohol-related hospitalizations of Medicare beneficiaries, only 2% (192) involved initiation of MAUD at the time of discharge, Eden Bernstein, MD, of Massachusetts General Hospital in Boston, and colleagues found.
    • In this small number, MAUD initiation at discharge was linked with a 42% decreased incidence of returning to the hospital within 30 days (incident rate ratio [IRR] 0.58, 95% CI 0.45-0.76, the researchers reported in JAMA Network Open. 
  • MedTech Dive informs us,
    • “Exact Sciences shared early results of a test it is developing with Mayo Clinic to screen for esophageal cancer and its precursors.
    • “The test, called Oncoguard Esophagus, uses an encapsulated sponge device to collect esophageal cells. DNA is extracted from the cells and processed in a PCR assay. The results from the assay are run through an algorithm, which provides a positive or negative result, Paul Limburg, Exact Sciences’ chief medical officer of screening, wrote in an email. 
    • “The test, which is designed to be less invasive than an endoscopy, detected esophageal adenocarcinoma and Barrett’s esophagus, a known precursor to the cancer, according to results published in Clinical Gastroenterology and Hepatology. The National Institutes of Health and Exact Sciences funded the study.”
  • Per Medscape,
    • “Artificial intelligence (AI) has identified two plant-based bioactive compounds with potential as glucagon-like-peptide-1 receptor (GLP-1R) agonists for weight loss as possible alternatives to pharmaceutical weight-loss drugs, but with potentially fewer side effects and oral administration.
    • “Using AI, the work aimed to identify novel, natural-derived bioactive compounds that may activate the GLP-1R, which is the site of action of existing weight loss pharmaceutical drugs including semaglutide (Wegovy, Novo Nordisk) and dual agonist tirzepatide (Zepbound, Eli Lilly).
    • “Presenter Elena Murcia, PhD, of the Structural Bioinformatics and High-Performance Computing Research Group & Eating Disorders Research Unit, Catholic University of Murcia, Murcia, Spain, will be sharing her work at the upcoming European Congress on Obesity (ECO 2024) in May.”

From the U.S. healthcare business front,

  • Beckers Payer Issues relates,
    • “UnitedHealthcare’s Surest is the organization’s fastest growing commercial health plan, boasting no deductibles and a shoppable healthcare experience built around price transparency.
    • “In March, Aon published an analysis of medical and pharmacy spending among Surest members in 2021 and 2022, totaling more than 92,000 and 156,000, respectively. Aon compared the experience of Surest members to that of a control group composed of members from a multi-employer database with matching geography, demographics, and medical and mental health comorbidities during the same time periods.
      • “Surest members had $365 lower total spend per-member per-year in 2021 and $412 lower spend in 2022.
      • “Surest’s total cost of care was 7.5% lower in 2021 and 7.7% lower in 2022.
      • “Results in 2022 were driven by 96.7% lower allowed medical claims and 78.8% lower allowed drug claims.
      • “Key drivers of cost efficiencies in 2022 were 93.1% lower professional spend and 71.5% lower specialty pharmacy spend.”
  • Healthexec and KFF discuss the state of concierge medicine.
    • “Nonprofit hospitals created largely to serve the poor are adding concierge physician practices, charging patients annual membership fees of $2,000 or more for easier access to their doctors.
    • “It’s a trend that began decades ago with physician practices. Thousands of doctors have shifted to the concierge model, in which they can increase their income while decreasing their patient load.”

Midweek Update

David Ermer–Congress, Federal employment benefits, Medicare, OPM, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • From a Senate press release,
    • Today, Senator Rick Scott and Senator Tom Carper announced the bipartisan FEHB Protection Act to stop fraud within the Federal Employee Health Benefits (FEHB) program, the largest employer-sponsored health insurance program in the country which covers eight million federal employees, retirees and family members. The FEHB Protection Act will codify Government Accountability Office (GAO) and Office of Inspector General (OIG) recommendations to require the Office of Personnel Management (OPM) to verify eligibility before adding family members, additionally, the bill requires an audit and removal of those ineligible for the program to ensure taxpayer dollars are used wisely and program benefits are protected for truly eligible individuals. This legislation follows a study conducted by the GAO at Senator Scott’s request, which revealed that OPM’s mismanagement of the FEHB program allowed ineligible individuals to obtain employer-sponsored health coverage at the hefty price tag of approximately $1 billion in taxpayer dollars every year.
    • The FEHBlog doubts the accuracy of GAO’s projection because half of the FEHB enrollment is self only and FEHB family sizes are notoriously small. In any case, this approach will not solve the problem because OPM reports enrollment actions and premiums separately even though using the HIPAA 820 electronic enrollment roster transaction would allow carriers to confirm receipt of premium for each enrollee systematically.
  • From the American Hospital Association News,
    • The Centers for Medicare & Medicaid Services March 27 finalized a rule proposed in 2022 to standardize Medicaid and CHIP enrollment and renewal processes and make it easier for eligible children and adults to stay covered. According to CMS, the final rule eliminates CHIP waiting periods, annual and lifetime coverage limits and the practice of locking children out of coverage if a family is unable to pay premiums; improves the transfer of children from Medicaid to CHIP when a family’s income rises; gives individuals at least 15 days to provide additional information when applying for the first time and 30 days to return documentation when renewing coverage; prohibits conducting renewals more often than every 12 months; and prohibits in-person interviews for older adults and those with disabilities. The rule takes effect 60 days after publication in the April 2 Federal Register.
  • and
    • The Centers for Medicare & Medicaid Services March 27 released the fiscal year 2025 proposed rule for inpatient rehabilitation facilities, which would update IRF payments by an estimated 2.8% overall (or $280 million) in FY 2025. This includes a 3.2% market basket update, which is reduced by a 0.4% productivity adjustment. IRF payments would be further decreased by an estimated $25 million due to the proposed update for outlier payments.
  • and
    • The Department of Health and Human Services’ Administration for Strategic Preparedness and Response and Centers for Medicare & Medicaid Services this week released a guide to health plan resources for health care providers impacted by the Change Healthcare cyberattack, including health plan contact information, noting in an accompanying letter that many providers continue to face significant disruptions as a result of the cyberattack or difficulty getting information from health plans about prospective payments and other flexibilities. The letter also encourages providers to review HHS’ voluntary cybersecurity performance goals.
  • It is worth adding that the United Healthcare Group updated its Change Healthcare Cyberattack response page today.

From the public health front,

  • The Washington Post reports,
    • “On Monday, government leaders in Puerto Rico declared a dengue epidemic after a spike in cases of the mosquito-borne disease hit the island.
    • “From the start of the year through March 10, there were 549 cases, including 341 hospitalizations and 29 severe cases, according to the most recent data provide by the Puerto Rico Department of Health. Cases are concentrated in cities including San Juan, Bayamon, Guaynabo and Carolina.
    • “Between 2010 and 2020, more than 30,000 dengue cases were reported from four U.S. territories, with Puerto Rico reporting the most. In 2012, Puerto Rico reported 199 deaths, which was the last time the commonwealth declared a dengue epidemic.”
  • The Wall Street Journal ponders,
    • “How closely should you be tracking your blood-sugar levels? * * *
    • “Soon, people without diabetes will be able to buy a monitor without needing to cajole a doctor into prescribing them one. The Food and Drug Administration recently approved the over-the-counter sale of a continuous glucose monitor, also known as a CGM. The devices allow people to continuously monitor their blood sugar levels.
    • “People who obsess over their health data or have an unhealthy relationship with food should avoid CGMs, most doctors say. Users might misinterpret normal glucose fluctuations as unhealthy, causing anxiety and prompting them to restrict certain foods. It isn’t clear that healthy patients would benefit from using a CGM over the long term.
    • “However, people at higher risk of developing diabetes, and those who are interested in working with their doctors to make lifestyle changes, might find it helpful. The technology could spot early signs of insulin resistance, possibly helping otherwise healthy people avoid Type 2 diabetes, some doctors say. 
    • “If we identify these patients sooner, we can suggest lifestyle modifications as well as maybe the initiation of weight-loss medications,” says Dr. Brenda Dorcely, an endocrinologist at NYU Langone Health.” 

Tidbits from the OPM FEHB carrier conference

  • The FEHBlog attended OPM’s virtual FEHB carrier conference today. Here are some tidbits.

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Beleaguered health system Steward Health Care has agreed to sell its physician network, Stewardship Health, to healthcare behemoth UnitedHealth Group for an undisclosed sum, according to documents filed with Massachusetts regulators on Tuesday.
    • “Under the deal, UnitedHealth’s care delivery subsidiary Optum Care would acquire Steward’s nine-state footprint of primary care providers and clinicians. It will also acquire all of Stewardship’s stock. 
    • “The Health Policy Commission, an independent Massachusetts agency tasked with monitoring state healthcare spending, will have 30 days to assess the potential impact of a Optum-Steward deal on healthcare costs, quality and access, HPC director David Seltz said in a statement. Already, some legislators and health M&A experts are urging a close review of the transaction, citing antitrust concerns.”
  • Per MedTech Dive,
    • “Johnson & Johnson is in talks to acquire Shockwave Medical, The Wall Street Journal reported Tuesday, citing people familiar with the matter.
    • “A deal could come in the next few weeks. However, the report noted that talks could fall through, or another company could pick up Shockwave. J&J and Shockwave both told MedTech Dive they do not comment on market rumors or speculation.
    • “Shockwave makes medical devices that break up calcium deposits in coronary arteries using sound pressure waves, a technique called intravascular lithotripsy (IVL).”
  • Beckers Payer Issues offers an interview with Aetna’s chief medical officer about managed care lessons from Medicaid to Medicare.

Weekend Update

David Ermer–Congress, Generative AI, Medical / Rx research, Mental health care, Obesity, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Govexec tells us,
    • “The Senate approved a $1.2 trillion spending package early Saturday shortly after a portion of the government was set to shut down, staving off the threat for the remainder of fiscal 2024. 
    • “The upper chamber moved to approve the measure after funding had lapsed, though shutdown procedures never commenced because an agreement was imminent. President Biden’s was expected to quickly sign the measure, which the House passed on Friday. The spending bill includes funding for the remaining parts of government that have not yet received full-year appropriations, including the departments of Defense, Treasury, Homeland Security, Labor, Health and Human Services, Education and State. 
  • Federal News Network notes,
    • “Congress is looking for details on federal telework as part of the latest government spending agreement — echoing months of return-to-office scrutiny from the House Oversight and Accountability committee.
    • “Among its many provisions, the agreement congressional appropriators reached Thursday for the back half of fiscal 2024 government spending bills lays out six new requirements on federal telework and return-to-office for federal employees.
    • “Within 90 days of the legislation’s enactment, the Office of Management and Budget will have to turn over all agencies’ return-to-office “action plans” outlined earlier this year, lawmakers said in an explanatory statement for the 2024 Financial Services and General Government bill.”
  • The House of Representatives and the Senate are on a two week long break. For those who are interested in an inside baseball approach, the Wall Street Journal examines the coalition government operating in the House of Representatives. Of course, the Democrats have a narrow majority in the Senate. All of that may change as a result of November’s national election.
  • OPM’s FEHB carrier conference will be held on Wednesday and Thursday this week.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Catherine, Princess of Wales, who Friday announced a cancer diagnosis, said she is getting preventative chemotherapy—a treatment that is given after surgery in hopes that it will increase the odds of a cure. 
    • “That the princess is undergoing preventative chemotherapy “suggests to me this is a curable cancer,” said Dr. Angela Jain, an assistant professor in the department of hematology and oncology at Fox Chase Cancer Center in Philadelphia. Jain and other doctors who spoke with The Wall Street Journal aren’t involved in Catherine’s care.
    • “Such chemotherapy, which oncologists call “adjuvant” therapy, is routinely given after surgical removal of a tumor for several months or for as long as a year, Jain said. Patients often get the treatment every two or three weeks. It doesn’t always stop the cancer from returning, but it can increase the odds of eliminating the disease.
    • “Not all cancers need chemo after surgery, but some do,” she said. “And usually you give that treatment with the hope and intention that this is a curable cancer, and chemo will reduce the risk of it coming back.” 
  • The Washington Post adds,
    • “In a recent panel at SXSW in Austin earlier this month, [Katie] Couric spoke about the rise in colorectal cancer. In particular, she hopes women better understand their risks. The risk of developing colorectal cancer is 1 in 23 for men and 1 in 25 for women, according to the American Cancer Society.  
    • “Women, especially younger women, believe this is an old man’s disease, and that’s simply not true,” she says. “Women are diagnosed with colorectal cancer as often as men. I think sometimes people get colons and prostates confused.”
    • “Less than half—44%—of Gen X women have gotten screened for colon cancer, and yet, “they are right in the sweet spot,” Couric says. And 43% of young women believe colon cancer is a men’s disease, of which nearly half think men are impacted two to three times as much as women, which is not correct, according to Medtronic, a health care technology company implementing AI in screening protocols.”  
  • and
    • “The Cancer Detectives,” a new American Experience documentary on PBS, tracks the fascinating and surprisingly frustrating backstory of the Pap smear, a cervical cancer screening test that’s now routine but was once anything but.
    • “The film takes viewers back to the days before Pap smears, a time when cervical cancer was rightfully feared by patients and doctors alike. A century ago, cervical cancer was a major killer of women. Early detection was impossible, and sexual stigma and shame kept women from discussing it.
    • “So it’s not surprising that when an immigrant physician from Greece, George Papanicolaou, nicknamed “Dr. Pap,” discovered a way to detect changes in cervical cells, his breakthrough was largely disregarded by the scientific community.
    • “It would take a massive public relations war against the unspeakable cancer to make the Pap smear a routine part of cervical cancer screening — a war waged in part by Black OB/GYN Helen Dickens, Japanese American illustrator Hashime Murayama and a group of women committed to cancer prevention.”
  • Fortune Well offers tips on how to stay in shape in your thirties, forties, and fifties. Gook luck.
  • The New York Times informs us,
    • “Most people, study after study shows, don’t take the medicines prescribed for them. It doesn’t matter what they are — statins, high blood pressure drugs, drugs to lower blood sugar, asthma drugs. Either patients never start taking them, or they stop.
    • “It’s a problem that doctors call nonadherence — the common human tendency to resist medical treatment — and it leads to countless deaths and billions of dollars of preventable medical costs each year.
    • “But that resistance may be overcome by the blockbuster obesity drugs Wegovy and Zepbound, which have astounded the world with the way they help people lose weight and keep it off. Though it’s still early days, and there is a paucity of data on compliance with the new drugs, doctors say they are noticing another astounding effect: Patients seem to take them faithfully, week in and week out.”
  • Per mHealth Intelligence,
    • “Using telehealth to provide palliative care support to rural family caregivers is a low-cost and feasible strategy for transitioning patients from hospital to home-based care, new research reveals.
    • “Conducted by researchers from the Mayo Clinic, Duke University, and the Minneapolis Veterans Affairs Health Care System, the study examines a telehealth-based palliative care support program for rural family caregivers who face challenges in accessing coordinated care for their loved ones during and after hospitalization. It also evaluated resource use, health system costs, and Medicare reimbursement pathways for this approach. Results were published in the American Journal of Hospice and Palliative Medicine.”
  • The MIT Technology News points out,
    • “Alex Zhavoronkov has been messing around with artificial intelligence for more than a decade. In 2016, the programmer and physicist was using AI to rank people by looks and sort through pictures of cats.
    • “Now he says his company, Insilico Medicine, has created the first “true AI drug” that’s advanced to a test of whether it can cure a fatal lung condition in humans. 
    • “Zhavoronkov says his drug is special because AI software not only helped decide what target inside a cell to interact with, but also what the drug’s chemical structure should be.”
  • From the Wall Street Journal,
    • “Elon Musk’s Neuralink introduced the first patient to receive its brain-computer implant, a 29-year-old diving-accident victim who showed during a livestream that he can now move a computer cursor using the device.
    • “In a nine-minute presentation streamed on Musk’s X platform Wednesday, Neuralink showed Noland Arbaugh directing the cursor around a screen to play a game of chess. Arbaugh said it feels like “using the force on a cursor,” referring to a concept from movies such as “Star Wars.” He said his surgery went well and he left the hospital after one day.
    • “Moving a computer cursor isn’t a big technical leap for brain-computer interfaces. An older brain chip first implanted in a human in 2004 also helped a paralyzed person move a cursor with only their thoughts. But the older chip must be attached to a device on the outside of the brain to transmit data, requiring wires protruding through the skin.
    • “Neuralink’s device transmits data wirelessly, and it can be used at home, outside of a laboratory setting.
    • “Another notable feature of Neuralink’s presentation was that Arbaugh was multitasking: playing chess while speaking about his experience getting the implant. Prior demonstrations of brain-computer interfaces have required dedicated attention to a particular task.”
  • and
    • “The more time you spend alone, the more likely you are to be lonely, right?
    • “Seems obvious. But it isn’t always true, according to a new study. For instance, it found that although, in general, those who spend the most time alone are the loneliest, that isn’t the case for young people; their time alone has little impact on how lonely they feel. What’s more, people who spend the least time alone tend to be slightly lonelier than those between the extremes. * * *
    • “Relationship status also was significant. Single people tended to spend more time alone than those in relationships and reported greater loneliness. Gender wasn’t a significant predictor of loneliness, the study found.
    • “The bottom line is that loneliness can’t simply be measured by the degree of a person’s social interaction.
    • “The degree of loneliness a person experiences is influenced by how much social interactions they have and by how much social interactions they feel they need,” Mehl says. “Beyond that, an important determinant of feelings of loneliness is the perceived meaning that a person derives from the social interactions they have.”

Friday Factoids

David Ermer–ACA, CDC, Congress, COVID-19, FDA, Generative AI, Medical / Rx research, Mental health care, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “House lawmakers approved a $1.2 trillion package of spending bills Friday over significant Republican opposition in the GOP-led chamber—sending the bill to the Senate, where lawmakers were working to pass the measure by a midnight deadline to avoid a partial government shutdown.
    • “The House vote was 286 to 134, barely exceeding the two-thirds supermajority needed to approve the bill under a special procedure needed by House Speaker Mike Johnson (R., La.) to bypass internal GOP divisions in his razor-thin majority.” * * *
    • “With the House done with the measure, Senate Majority Leader Chuck Schumer(D., N.Y.) took steps to begin the process of considering the bills. This typically takes several days, but could happen within hours if all 100 senators agree to a quicker voting timeline. Funding is scheduled to run out for the Defense Department and several other agencies at 12:01 a.m. on Saturday, which would force them to shut down nonessential operations.
    • “President Biden has said he would sign the legislation.”
  • Beckers Payer Issues informs us,
    • “A group of Republican lawmakers are asking CMS to reconsider its proposed 2025 rates for Medicare Advantage. 
    • “Forty-five lawmakers signed a letter to CMS Administrator Chiquita Brooks-LaSure expressing concerns the proposed rates could lead health plans to cut benefits for older adults and harm the viability of the program. 
    • “It is baffling that CMS has proposed a nearly 0.2% cut to the Medicare Advantage insurer reimbursement rate for 2025,” the lawmakers wrote. 
    • “CMS proposed cutting benchmark payments for Medicare Advantage plans by 0.2% in 2025. The agency says plans should expect to see 3.7% higher revenue overall, with an MA risk score trend of 3.86% — the average increase in risk adjustment payments year over year — offsetting risk model revisions and a projected decline in star rating bonuses. 
    • “The insurance industry has decried the rate notice, calling it insufficient to cover rising medical costs among MA beneficiaries. Some insurers have said they will likely cut supplemental benefits for beneficiaries to offset decreasing benchmark payments.” 
  • The Centers for Medicare and Medicaid Services announced,
    • “Today, the U.S. Department of Health and Human Services (HHS) issued four new reports showing that President Biden’s efforts to strengthen the Affordable Care Act (ACA) are linked to historic gains in Americans’ health insurance coverage. Today’s announcements include a report from the Centers for Medicare & Medicaid Services (CMS) showing that over 21 million consumers selected or were automatically re-enrolled in health insurance coverage through HealthCare.gov and State-based Marketplaces during 2024’s Open Enrollment Period (OEP). Three reports from HHS’s Office of the Assistant Secretary for Planning and Evaluation (ASPE) highlight current enrollment trends, enrollment trends broken down by race and ethnicity, and how the ACA Marketplaces have evolved and strengthened during the first ten years. ASPE analysis shows that today over 45 million people have coverage thanks to the Affordable Care Act’s Marketplaces and Medicaid expansion.” 
    • People buy it because of the low price but do they use it effectively?

From the public health and medical research front,

  • The Centers for Disease Control inform us
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare remains elevated nationally but is decreasing across many areas of the country. This week, 9 jurisdictions experienced high or very high activity compared to 17 jurisdictions the previous week.
    • “Nationally, emergency department visits with diagnosed COVID-19, influenza, and RSV are decreasing.
    • “Nationally, COVID-19, influenza, and RSV test positivity decreased compared to the previous week.
    • “Nationally, COVID-19 wastewater viral activity levels, which reflects both symptomatic and asymptomatic infections, is low.
    • “Reported on Friday, March 22nd, 2024.”
  • The New York Times considers “What’s Next for the Coronavirus? Scientists studying the virus’s continuing evolution, and the body’s immune responses, hope to head off a resurgence and to better understand long Covid.”
    • “We’re not in the acute phases of a pandemic anymore, and I think it’s understandable and probably a good thing” that most people, including scientists, have returned to their prepandemic lives, said Jesse Bloom, an evolutionary biologist at the Fred Hutchinson Cancer Center in Seattle.
    • “That said, the virus is still evolving, it’s still infecting large numbers of people,” he added. “We need to keep tracking this.”
  • That’s a reassuring statement.
  • The Wall Street Journal tells us,
    • “Grief is well recognized as a process people go through after losing a loved one. But less attention is paid to the grief of people with chronic illnesses and disabilities for the losses they’ve suffered. 
    • “The grief of those with chronic health issues—for the loss of capabilities, for changed or ruptured relationships, for changes in appearance, for the forced end of a career, or for former dreams for the future—can last for long periods and recur often, as losses and uncertainty become a constant feature of life.
    • “What’s the next thing that [my conditions are] going to take from me?” asks Andrew Gurza, a disability-awareness consultant who has cerebral palsy and chronic illness. “What’s the next thing that I’m not able to do anymore?”
    • “People who have intimate knowledge of the grief that comes with chronic health issues say it has a trajectory all its own—a trajectory that many mental-health professionals, friends and family often don’t understand. The idea that everyone goes through five stages of grief—denial, anger, bargaining, depression and acceptance—doesn’t ring true for many disabled people. Chronic illness, other disabilities and the grief they bring often run an unpredictable course, easing but then flaring up again, a cycle that can recur over time. * * *
    • “Mel Sebastiani, an end-of-life doula and former chaplain who is seeking diagnosis for her own neurological illness, says that with her clients, she emphasizes “deep listening and finding out what that person likes, misses—and [finding] a way to weave it back into their lives in a way that they can manage.” 
    • “For Sebastiani herself, that meant coping with new symptoms by switching from steep mountain-trail hikes to walks on the beach to collect and photograph sea glass and other natural treasures near her home in Rehoboth Beach, Del.  
    • “While grief will persist, it may not always be a negative or debilitating experience. “You can be in grief and be a strong person,” Sebastiani says.
    • “Grief is a powerful tool and coping mechanism to realize where you are in the moment, where your life is a reflection on your life in the past,” she says. “And it’s kind of a gift in that sense, because many healthy people never reflect on any of that.”
  • The International End of Life Doula Association discusses their profession.
    • “A doula can become involved any time in a person’s life. We offer support when people are impacted by a life changing illness, after a terminal diagnosis, when death is imminent, or even after a death—to help with light grief support. Sometimes family members or loved ones of the person dying seek support and guidance from end-of-life doulas.
    • “Doulas normalize deathcare by creating spaces to hold conversations leading to increased communication and increased spiritual and emotional well being. When individuals plan for death, they have autonomy over their decisions and are able to clearly define their end-of-life wishes with family and loved ones. While there are alternative names for end-of-life doulas like death doula, death midwife, death coach, end-of-life coach—we all seek to provide compassionate deathcare.”
  • Medscape lets us know,
    • “Use of statin drugs was associated with improved mortality in older nursing home residents, regardless of dementia status, a new study showed.
    • “The study is among the first to explore whether statin use in older nursing home residents offers a mortality benefit, especially among individuals with dementia, a group largely excluded from earlier statin trials.
    • “Investigators’ analysis of 4 years of data on nearly 300,000 nursing home residents revealed that statin use was associated with a 40% lower risk for all-cause mortality than statin nonuse in those without dementia and a 20% lower risk in those with dementia.
    • “These findings may provide evidence that supports the continued use of statins in older nursing home patients with multiple medical conditions,” lead author Julie Lorraine O’Sullivan, PhD, of the Charité – Universitatsmedizin Berlin, Freie Universität Berlin, German Center for Mental Health, Berlin, Germany, and colleagues wrote.
    • “The study was published online on February 27 in Neurology.”
  • and
    • “A new way of using artificial intelligence (AI) can predict breast cancer five years in advance with impressive accuracy — and unlike previous AI models, we know how this one works.
    • “The new AI system, called AsymMirai, simplifies previous models by solely comparing differences between right and left breasts to predict risk. It could potentially save lives, prevent unnecessary testing, and save the healthcare system money, its creators say.
    • “With traditional AI, you ask it a question and it spits out an answer, but no one really knows how it makes its decisions. It’s a black box,” said Jon Donnelly, a PhD student in the Department of Computer Science at Duke University, Durham, North Carolina, and first author on a new paper in Radiology describing the model.
    • “With our approach, people know how the algorithm comes up with its output so they can fact-check it and trust it,” he said.”
  • mHealth Intelligence relates,
    • “Direct-to-consumer (DTC) telehealth visits resulted in higher rates of antibiotic prescriptions for pediatric patients than telehealth visits conducted by primary care physicians (PCPs), according to a new study by UPMC.
    • “Published in JAMA Open Network, the study aimed to assess antibiotic prescriptions for pediatric acute respiratory tract infections during telehealth visits with PCPs compared with virtual visits conducted by commercial DTC telehealth companies.
    • “High rates of antibiotic prescriptions raise concerns about antibiotic resistance, which occurs when germs develop the ability to defeat the drugs designed to kill them. Antibiotic-resistant infections can be challenging to treat, often requiring second- and third-line treatments that can have harmful side effects. In some cases, these infections have no treatment options.”

From the Food and Drug Administration (FDA) front,

  • Per an FDA press release,
    • “Today, the FDA issued an emergency use authorization for Pemgarda (pemivibart) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and adolescents (12 years of age and older weighing at least 40 kilograms [about 88 pounds]). 
      Pemgarda is authorized for individuals:
      • “who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2; 
      • “and who have moderate-to-severe immune compromise due to a medical condition or due to taking immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination. 
    • “For more information about Pemgarda and its authorization, please see the resources available on the FDA’s Emergency Use Authorization webpage.”
  • Per Medpage Today,
    • “The FDA approved label expansions for bempedoic acid (Nexletol) and bempedoic acid/ezetimibe (Nexlizet) so they can be used more broadly as cardiovascular prevention drugs, Esperion announced Fridayopens in a new tab or window.
    • “Based on the CLEAR Outcomes trialopens in a new tab or window, the two adenosine triphosphate (ATP) citrate lyase inhibitor drugs are now indicated for adults with either established atherosclerotic cardiovascular disease (CVD) or high risk for a CVD event to reduce the risk of myocardial infarction (MI) and coronary revascularization. Approval does not require patients to be on existing statin therapy.”
  • Per MedTech Dive,
    • “The Food and Drug Administration’s plan to expand oversight of laboratory-developed tests threatens to prevent or delay patient access to innovative diagnostics, industry groups warned in congressional testimony Thursday.
    • “The FDA’s final rule on LDT regulation, which could come as soon as April, has unleashed a fierce debate over how to protect the health and safety of patients by ensuring tests developed in a single laboratory are accurate and reliable but still reach the market quickly. The agency received nearly 7,000 comments on the proposed rule, which would broaden its authority to regulate the tests.
    • “Laboratory-developed tests really are the cutting edge when it comes to leading the foundational work for personalized medicine,” Susan Van Meter, president of the American Clinical Laboratory Association, told a House Energy and Commerce health subcommittee hearing. The Clinical Laboratory Improvement Amendments program certifies LDTs under the current regulatory framework.”

From the U.S. healthcare business front,

  • Beckers Hospital Review points out,
    • Jellico (Tenn.) Regional Hospital, a 25-bed critical access facility, closed March 9, making it the 36th rural hospital to shutter or no longer provide inpatient services since 2020, according to data compiled by the University of North Carolina’s Cecil G. Sheps Center for Health Services Research. 
    • The closures highlight the heightened financial challenges that rural hospitals face amid persisting workforce shortages, rising costs and leveling reimbursement. In addition, only 45% of rural hospitals now offer labor and delivery services, and in 10 states, less than 33% do, according to the Center for Healthcare Quality and Payment Reform.
    • The article lists the rural hospitals that have closed.
  • Per Fierce Healthcare,
    • “Uncomfortable waiting rooms. Revealing hospital gowns. Confusing insurance. Exhausting travel between appointments.
    • “These are just some reasons cancer is in desperate need of a rebrand, experts said at this year’s SXSW conference.
    • “Oncology was a major focus across multiple sessions, where clinicians and patient advocates called for better access to specialty care, more thoughtful communication with patients and continued collaboration across stakeholders.”
  • Per HR Dive,
    • “Seventy-one percent of senior finance leaders plan to give raises of at least 4% in 2024, outpacing inflation in most areas, according to the results of a survey by Gartner, Inc., which were released March 20. The majority (58%) said they intended to raise compensation by between 4% and 9% this year. 
    • “Compensation ranked second among the areas where leaders said they planned to increase budgets this year, beaten only by technology investments, which were a priority for 82% of the 296 CFOs and senior finance leaders surveyed in December. However, fewer leaders intended to award raises of 10% or more, the survey found. 
    • “Even with tighter economic policy and pressure from boards and investors on profitable growth and employee productivity, CFOs are outpacing inflation that has now almost returned to a neutral rate below 3%,” Alexander Bant, chief of research in the Gartner finance practice, said in a statement. “The fact that most CFOs are planning for pay growth that exceeds the level of inflation indicates how tight the labor market is right now and how important it is to find and retain top talent.”
  • Mercer Consulting informs us,
    • “Gen Z is redefining the employer-employee relationship and that includes how voluntary benefits are structured and offered.  
    • “By 2025, Gen Z (those born 1997−2021) will comprise 27% of the workforce, and this group has far different expectations than their older peers. With voluntary benefits supporting all aspects of total rewards, the right solutions can help solve the most pressing talent questions — including how to resonate with the newbies in the workplace. Mercer’s latest National Survey of Employer-Sponsored Health Plans found that as employers have broadened the range of voluntary benefits offered, a growing portion of their workers are choosing to enroll in them – 45% of eligible employees on average, up sharply from 36% in 2022. * * *
    • “Gen Z respondents in the survey were more likely than older workers to say that benefits are a reason to stay with their employer. Designing the right benefits program is a way to partner with Gen Z on improving their physical, mental and emotional health and their financial well-being — and it shows that their employer is listening and cares about their holistic experience.”   
  • Per Healthcare Dive,
    • “Consumers are willing to share their health data, but they’re becoming pickier about which entities they’ll provide that information to, according to a survey from consultancy and digital health venture capital firm Rock Health. 
    • “Ninety percent of respondents said they’d share their data with at least one healthcare entity, the survey found. While 64% reported they’d offer data to a doctor or clinician, only 7% would share with a technology company.
    • “Consumers were also willing to share data with fewer entities in 2023 compared with 2020. The wariness is a warning for the sector, as data sharing is key to informing new treatments, studying disease trends and training healthcare artificial intelligence models, the report said.” 

Thursday Miscellany

David Ermer–AHRQ, CDC, CMS, Congress, Cybersecurity, Electronic health records, FDA, HSA, Medical / Rx research, Medicare, Mental health care, NCQA, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Roll Call reports,
    • “Lawmakers released a more than $1.2 trillion, six-bill appropriations package early Thursday morning, less than 48 hours ahead of a Friday night deadline for this second and final wrapup measure for the fiscal year that began Oct. 1. 
    • “Both parties were touting “wins” in the package well before unveiling the massive 1,012-page bill, which had already won President Joe Biden’s blessing and pledge to sign it “immediately.” That, plus the lure of a two-week recess, should help get the package over the finish line, though it seems likely to slip past the 11:59 p.m. Friday cutoff for the current stopgap spending law.
    • “But lawmakers weren’t really sweating the prospect of a weekend funding lapse, given its limited impact on government operations — especially with Friday’s expected House passage likely to be a strong signal of congressional intent to keep the lights on.”
  • The bill includes appropriations for OPM (pages 247 – 250) and its Inspector General (page 250) plus the three now standard appropriations measures:
    • A prohibition against imposing full Cost Accounting Standards coverage on FEHB carriers. Division B, Section 611, page 268.
    • The Hyde amendment limiting FEHB coverage of abortions to cases “where the life of the mother would be endangered if the fetus were carried to term, or the pregnancy is the result of an act of rape or incest.” Division B, Section 613 and 614, pages 268 – 269.
    • A contraceptive prescription drug coverage mandate with conscience protections for FEHB plans and healthcare providers. Division B, Section 726, page 298.
  • The American Hospital Association News discusses HHS appropriations, which also are included in this bill.
    • “The House may vote on the measure Friday, with Senate action expected over the weekend. A short government shutdown may occur over the weekend, depending how long it takes both chambers to pass the measure and for President Biden to sign it into law.” 
  • Govexec points out “the nine biggest agency and program reforms in the final FY24 spending package.”
  • The Wall Street Journal scoops,
    • “Some Medicare members could get help paying for the popular new weight-loss drug Wegovy—as long as they have a history of heart disease and are using it to prevent recurring heart attacks and strokes.
    • “Medicare Part D drug-benefit plans—which are administered by private insurers—may cover anti-obesity medications if the drugs receive approval for an additional use that is considered medically accepted under federal law, the Centers for Medicare and Medicaid Services told The Wall Street Journal on Thursday. * * *
    • “Some Medicare members could get help paying for the popular new weight-loss drug Wegovy—as long as they have a history of heart disease and are using it to prevent recurring heart attacks and strokes.
    • “Medicare Part D drug-benefit plans—which are administered by private insurers—may cover anti-obesity medications if the drugs receive approval for an additional use that is considered medically accepted under federal law, the Centers for Medicare and Medicaid Services told The Wall Street Journal on Thursday.”
  • STAT News adds,
    • “Early data regarding the use of GLP-1 medications like Ozempic and Wegovy to treat addiction is “very, very, exciting,” Nora Volkow, the director of the National Institute on Drug Abuse, said Thursday.
    • “But even as she expressed enthusiasm for the new drugs’ potential, Volkow criticized pharmaceutical companies for neglecting a moral imperative to develop new addiction treatments — but acknowledged that the health system more broadly doesn’t incentivize drug companies to treat the U.S. drug crisis with urgency.”
  • The U.S. Preventive Services Task Force finalized its research plan for re-evaluating its September 2019 recommendations on the topic of medications to reduce the risk of breast cancer.
  • Beckers Health IT interviews Alexandra Mugge, chief health informatics officer at CMS, about the agency’s efforts “to expedite prior authorizations, through digitization and better data exchange, saving the healthcare industry $15 billion over a decade — in the hopes of one day having the decisions made instantaneously, right in the EHR.”

From the Food and Drug Administration front,

  • Per a press release,
    • “Today, the U.S. Food and Drug Administration approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older. Duvyzat is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD. It is a histone deacetylase (HDAC) inhibitor that works by targeting pathogenic processes to reduce inflammation and loss of muscle.
    • “DMD denies the opportunity for a healthy life to the children it affects. The FDA is committed to advancing the development of new therapies for DMD,” said Emily Freilich, M.D., director of the Division of Neurology 1, Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “This approval provides another treatment option to help reduce the burden of this progressive, devastating disease for individuals impacted by DMD regardless of genetic mutation.”
  • MedTech Dive informs us,
    • Johnson & Johnson subsidiary Abiomed recalled its Impella left sided blood pumps for risk that the devices could perforate the heart during a procedure. The recall began on Dec. 27 with Abiomed updating its instructions for use.
    • The Food and Drug Administration identified the recall as a Class I event, the most serious type of recall, in a Thursday notice. The agency has received 129 reports of serious injuries, including 49 deaths, related to the problem. 
    • Abiomed’s Impella heart pumps, which are used to support the heart during procedures or during cardiogenic shock, were the subject of four Class I recalls last year, including the latest recall. The company also received an FDA warning letter for quality problems with Impella and software used in the device that had not been authorized by the agency.

From the public health and medical research front,

  • The CDC shares with us,
    • Data from the National Vital Statistics System
      • Life expectancy for the U.S. population in 2022 was 77.5 years, an increase of 1.1 years from 2021.
      • The age-adjusted death rate decreased by 9.2% from 879.7 deaths per 100,000 standard population in 2021 to 798.8 in 2022.
      • Age-specific death rates increased from 2021 to 2022 for age groups 1–4 and 5–14 years and decreased for all age groups 15 years and older.
      • The 10 leading causes of death in 2022 remained the same as in 2021, although some causes changed ranks. Heart disease and cancer remained the top 2 leading causes in 2022.
      • The infant mortality rate was 560.4 infant deaths per 100,000 live births in 2022, an increase of 3.1% from the rate in 2021 (543.6).
  • STAT News adds,
    • “The U.S. recorded 107,941 drug overdose deaths in 2022, according to a new federal report — a total that marks an all-time record but also shows signs that the country’s overdose rate may finally be leveling off after years of steady increase.
    • “The 2022 total marks only a slight increase from the drug death toll of 106,699 the year before, according to the Centers for Disease Control and Prevention. The flattening of drug death rates could provide a rare glimmer of hope amid the bleak U.S. drug crisis, which has seen overdose rates rise inexorably for the past two decades and especially during the Covid-19 pandemic.
    • “A large majority of those deaths were driven by the potent synthetic opioid fentanyl. Since emerging in the drug supply in the mid-2010s, fentanyl has increasingly come to dominate the U.S. illicit drug market. Even as fentanyl deaths have skyrocketed, the share of deaths involving other opioids — like heroin, methadone, and prescription painkillers — has decreased.”
  • The Washington Post reports,
    • “After once losing hope because of end-stage kidney disease, a 62-year-old man is now the first living person to receive a genetically edited kidney from a pig, according to doctors at Massachusetts General Hospital who performed the landmark surgery Saturday.
    • “Richard Slayman, whom doctors praised for his courage, is doing well after the four-hour surgery and is expected to be discharged from the Boston hospital soon, officials said.
    • “The advance, which builds on decades of work, gives hope to the hundreds of thousands of Americans who depend on dialysis machines to do the work of their failing kidneys. Each day, 17 Americans die awaiting a kidney transplant, a problem further complicated by unequal access given to Black and other patients. Doctors expressed hope that using pigs to vastly increase the supply of kidneys might correct the inequity.”
  • The Wall Street Journal lets us know,
    • “A new class of anticoagulant drugs on the horizon is taking fresh aim at one of cardiology’s toughest challenges: how to prevent blood clots that cause heart attacks and strokes, without leaving patients at risk of bleeding.
    • “At least a half-dozen experimental blood thinners are in development that inhibit a protein called factor XI, one of several blood factors that regulate how the body forms clots. * * *
    • “Any factor XI agent that reaches the market would likely represent an important advance over drugs called factor Xa inhibitors, a blockbuster class of medicines dominated by Eliquis and Xarelto. Since they were approved just over a decade ago, these drugs have supplanted warfarin as the standard-of-care anticoagulant to prevent stroke in patients with the heart-rhythm disorder atrial fibrillation as well as other indications.”
  • HealthDay informs us,
    • “About 1 in every 10 U.S. children ages 5 to 17 has been diagnosed with attention deficit hyperactivity disorder (ADHD), according to the latest government statistics.
    • “The data from the National Health Interview Survey covers the years 2020 through 2022 and came from in-person or phone interviews involving a representative sample of American homes.
    • “It found that 11.3% of school-age children have been diagnosed with ADHD, with boys more likely to have this diagnosis (14.5%) than girls (8%), according to report authors Cynthia Reuben and Nazik Elgaddal, of the National Center for Health Statistics (NCHS).
    • “ADHD is diagnosed more often among white children (13.4%) than Black youngsters (10.8%) or Hispanic (8.9%) kids, the survey also showed. 
    • “Family income seemed to matter, too:  As income levels rose, the rate of child ADHD diagnoses declined.”
  • WTW, an actuarial consulting firm, offers insights on hepatitis C, HPV vaccine and value based insurance design.

From the U.S. healthcare business front,

  • STAT News reports,
    • “The last decade has seen billions of dollars flow into digital health companies that promise to improve outcomes for the 38 million Americans living with type 2 diabetes. Their products aren’t cheap, but in the long term, they pitch to health plans and employers that these digital tools will help cut health care costs by preventing serious complications like amputation and kidney failure.
    • “A systematic review by the Peterson Health Technology Institute found, though, that digital tools used to manage diabetes with the help of finger-stick blood glucose readings don’t result in clinically meaningful improvements over standard care. As a result, they don’t reduce health care spending — they drive it up.
    • “Most of the solutions in this category do not deliver clinical benefits that justify their cost,” Caroline Pearson, executive director of the institute, told STAT. Despite finding that some populations may benefit, the report concludes that current evidence doesn’t support broader adoption for most products.”
  • Plan Sponsor notes,
    • “In the face of rising health care expenditures and out-of-pocket spending, average health savings account balances have also steadily increased since the COVID-19 pandemic, according to new data from the Employee Benefit Research Institute.
    • “The average HSA balance rose to $4,418 at the end of 2022 from $2,711 at the start of the year, the most recent data available in EBRI’s database, given that participants can still contribute to 2023 HSAs until taxes are due in April.
    • “Jake Spiegel, a research associate at EBRI, says he sees this trend continuing in 2023 and into the start of 2024 as well.
    • “EBRI’s analysis revealed two predominant factors associated with higher average account balances. The first was that age is strongly associated with higher HSA balances: the older the accountholder, the higher the average balance.”
  • Beckers Hospital Review lets us know,
    • “Change Healthcare said it has reinstated Amazon cloud services for two of its platforms a month into a cyberattack against the company.
    • “The UnitedHealth Group and Optum subsidiary said March 20 it restored Amazon Web Services from backups for Assurance, a claims and remittance management program, and claims clearinghouse Relay Exchange. Change said it rebuilt authentication services for the solutions on a new network with the help of cybersecurity firms Palo Alto Networks and Mandiant, a Google subsidiary. The company said it is also testing the security of the external-facing parts of those applications.”
  • Per the Society for Human Resource Management,
    • “Employees are experiencing more mental health struggles and overall negative feelings about their work, underscoring an “urgent need” for employers to take more aggressive measures to help with their benefits offerings.
    • “Employees are now more likely to experience negative feelings at work, including stress (12 percent more likely) and burnout (17 percent more likely) than they were pre-pandemic (2019), according to new data from MetLife. Employees are also 51 percent more likely to feel depressed at work than they were pre-pandemic as they face what the insurer calls a “complex macro environment and permacrisis state”—a state which has included the pandemic, persistent high inflation, international turmoil and war, and more.
    • “Those are among the findings in MetLife’s 22nd annual U.S. Employee Benefit Trends Study, released March 18—data indicating that employers may have to revisit benefits offerings to not only support employees, but retain them.”
  • HR Dive explains “How menopausal and other reproductive health benefits can help retain women” and “Data shows that fertility treatments are extremely valuable to workers who need them. Here’s why one people officer is working on integrating them.”
  • STAT News relates,
    • “Just as Pfizer spooked Wall Street after its record pandemic revenue came parabolically back to earth, BioNTech, the company’s Covid-19 vaccine partner, is now dealing with investor malaise of its own.
    • “Shares in the German firm fell about 5% yesterday, hitting a 52-week low, after the company reported disappointing financials. BioNTech’s cut of Covid vaccine revenue fell by about more than three-quarters last year, missing analyst estimates and leading the company to lower its projections for 2024.
    • “Now BioNTech, much like Pfizer, is making the case that its future in oncology will compensate for the rapid erosion in demand for Covid vaccines. The company has more than 20 cancer medicines in its pipeline, including late-stage treatments for tumors of the breast and lung that could hit the market in the next two years.”
  • Per Healthcare Dive,
    • “Walgreens-backed VillageMD sold 11 locations in Rhode Island to Boston-based medical group management firm Arches Medical Partners for an undisclosed sum, Arches said Wednesday.
    • “The practices, which include about 75,000 patients, joined Arches on March 2, according to VillageMD’s website. 
    • “The deal follows VillageMD clinic closures. The primary care chain recently exited Florida — once one of chain’s largest markets — and plans to withdraw from its home state in Illinois next month.”

Midweek Update

David Ermer–CMS, Congress, COVID-19, Cybersecurity, Employee Wellness Programs, FDA, Generative AI, Medical / Rx research, Mental health care, Obesity, OPM, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Roll Call reports,
    • “Speaker Mike Johnson, R-La., and his top lieutenants on Wednesday morning moved to quell reservations among their conference about the emerging $1.2 trillion-plus final spending package headed for a vote likely on Friday, while their Democratic counterparts did likewise in a separate meeting.
    • “Appropriators were scrambling under a tight timeline to finish drafting the measure, which is taking longer than expected due to a last-minute decision to write a full-year Homeland Security bill. But Johnson told reporters after a GOP conference meeting that text is expected as soon as Wednesday afternoon.
    • “Other sources expected the bill drop to slip to Thursday, with the standard “reading out” of the DHS title, to catch any errors before posting, not even expected to begin until later Wednesday. But no matter: Lawmakers said they expect the chamber to vote as soon as Friday, regardless of a 72-hour review rule. * * *
    • “Final passage wouldn’t come until this weekend at the earliest, and senators are working to accommodate Sen. Susan Collins, R-Maine, who has never missed a vote but will be attending her mother’s funeral on Saturday. That could push votes off until Sunday or Monday, though few are worried at this point about the effects of such a brief funding lapse. 
    • “I don’t think we’ll do a [continuing resolution],” Johnson said.”
  • The American Hospital Association (AHA) News informs us,
    • “The House Energy and Commerce Committee March 20 unanimously passed AHA-supported legislation to reauthorize through 2029 the Dr. Lorna Breen Health Care Provider Protection Act (H.R. 7153), which provides grants to help health care organizations offer behavioral health services for front-line health care workers. The bill also would reauthorize a national campaign that provides hospital leaders with evidence-based solutions to support worker well-being. Without congressional action, the law will expire at the end of this year.”
  • and
    • “Congress should address any statutory constraints that prevent the Centers for Medicare & Medicaid Services and Department of Health and Human Services from adequately helping hospitals and other health care providers impacted by the Change Healthcare cyberattack, AHA said a letter submitted to the House Ways and Means Committee for a hearing March 20 with HHS Secretary Xavier Becerra on fiscal year 2025 funding for HHS.”
  • Govexec tells us,
    • “The top senator with direct oversight of the U.S. Postal Service is calling on its leadership to pause its overhaul of the agency’s mailing network due to potential impacts they are having on delivery, rejecting USPS assertions that is has provided transparency. 
    • “USPS should not continue its nationwide operational reforms until it can prove the changes will not negatively impact mail service, Sen. Gary Peters, D-Mich., who chairs the Senate Homeland Security and Governmental Affairs Committee, said in a letter to Postmaster General Louis DeJoy. Agency leadership said in response to the letter it has offered volumes of documents and many staff-level briefings to Congress, though Peters said USPS ignored many of his requests for additional information on its efforts and left Congress uncertain about the fallout that could befall postal customers.”
  • On March 18, 2024, the Office of Management and Budget’s Office of Information and Regulatory Affairs received for final regulatory review an OPM proposed rule with additional requirements and clarifications for the Postal Service Health Benefits Program (RIN 3206-AO59).
  • The AHA News tells us,
    • “U.S. health care organizations should immediately transition away from using certain unauthorized plastic syringes made in China by Jiangsu Caina Medical Co. and Jiangsu Shenli Medical Production Co., and should only use other plastic syringes made in China until they can transition to alternatives, the Food and Drug Administration announced March 19, citing potential quality and performance issues. The recommendations do not apply to glass syringes, pre-filled syringes, or syringes used for oral or topical purposes, FDA said. The agency advises health care providers to confirm the manufacturing location by reviewing the labeling, outer packaging, or contacting the supplier or group purchasing organization.”
  • The Assistant Secretary of Labor for Employee Benefit Security, Lisa M. Gomez, posted on her blog about “Health and Money Smarts for Women.”
  • Fierce Healthcare lets us know,
    • “The Employee Retirement Income Security Act, or ERISA, is turning 50 this year and lawmakers are curious to hear about how the law could be updated to increase coverage affordability and care access.
    • “Payers and providers, it turns out, have very different ideas on where Congress should focus its efforts.
    • “In response to the House Committee on Education and the Workforce’s January request for information, lobbying groups representing both sides of the industry weighed in on the act that outlines federal guidelines for employee benefit plans, including employer-sponsored group health plans.”
    • The article delves into these comments.
  • Newfront offers insights about 2024 RxDC reporting considerations. The reports are due June 1, 2025.
  • The Congressional Budget Office released a presentation about “The Federal Perspective on Coverage of medications to treat obesity. Assuming Congress allows Medicare to cover anti-obesity medications (AOM),
  • “The future price trajectory of AOMs is highly uncertain.
    • “CBO expects semaglutide to be selected for price negotiation by the Secretary of Health and Human Services within the next few years, which would lower its price (and potentially the prices of other drugs in the AOM class).
    • “CBO expects generic competition for semaglutide and tirzepatide to start in earnest in the second decade of a policy allowing Medicare Part D to cover AOMs.
    • “New AOMs are expected to become available. The new drugs might be more effective, have fewer side effects, or be taken less frequently or more easily than current medications. Those improvements could translate to higher prices, on average, even if prices decline for drugs that exist today.”
  • See also the Beckers Hospital Review article below on the next generation of AMOs.
  • Healthcare Dive tells us,
    • “The Medicare Advisory Payment Commission, which advises Congress on Medicare policy, is recommending boosting hospital payment rates by 1.5% in 2025 and base physician payment rates by 1.3% above current law, according to its annual report released Friday. 
    • “MedPAC suggested tying the rate of physician payment increasesmoving forward to the Medicare Economic Index, an annual measure of practice cost inflation. MedPAC suggested payments increase “by the amount specified in current law plus 50% of the projected increase in the MEI.”
    • “Provider groups, including the Medical Group Management Association and American Medical Association, have said the proposed payment increases are inadequate.”

From the public health and medical research front,

  • The Washington Post reports,
    • “More than two-thirds of young children in Chicago could be exposed to lead-contaminated water, according to an estimate by the Johns Hopkins Bloomberg School of Public Health and the Stanford University School of Medicine.
    • “The research, published Monday in the journal JAMA Pediatrics, estimated that 68 percent of children under the age of 6 in Chicago are exposed to lead-contaminated drinking water. Of that group, 19 percent primarily use unfiltered tap water, which was associated with a greater increase in blood lead levels.
    • “The extent of lead contamination of tap water in Chicago is disheartening — it’s not something we should be seeing in 2024,” lead author Benjamin Huynh, assistant professor of environmental health and engineering at the Johns Hopkins Bloomberg School of Public Health, said in a news release.”
  • The Wall Street Journal relates,
    • “Debi Lucas had a tremor in her arm. Her feet froze when she tried to walk and she fell into her coffee table, busting her lip. 
    • “She went to a neurologist who thought she had Parkinson’s disease. Doctors normally diagnose the neurodegenerative condition by symptoms. Lucas, 59, had them. 
    • “But the neurologist, Dr. Jason Crowell, couldn’t be sure. The symptoms might be related to a traumatic brain injury Lucas suffered in a car accident decades earlier, he thought. Or they might be from her medications. 
    • “To find an answer, Crowell turned to a new test: a skin biopsy that can detect an abnormal protein people with Parkinson’s have inside their nerves. He took samples of skin near her ankle, knee and shoulder and sent them to a lab. 
    • “The results confirmed that Lucas has Parkinson’s. The diagnosis was scary, but Lucas finally knew what was causing her symptoms. “I was glad to have a name on it,” she said. 
    • “The test sped her diagnosis, said Crowell, a movement-disorders neurologist at the Norton Neuroscience Institute in Louisville, Ky. “It just gives me more confidence,” he said. 
    • “The skin test is an important part of progress researchers are making against Parkinson’s, the second-most common age-related neurodegenerative condition, which is on the rise and a major driver of disability, dementia and death. The test Lucas received, made by CND Life Sciences, a medical technology company in Scottsdale, Ariz., is one of a few in use or development to allow doctors to diagnose Parkinson’s based on biology rather than symptoms that can take years to appear“.
  • Medscape explains “why a new lung cancer treatment is so promising.”
  • MedPage Today notes,
    • “The FDA has approved aprocitentan (Tryvio), making it the first endothelin receptor antagonist for the treatment of high blood pressure (BP), Idorsia Pharmaceuticals announced on Wednesday.
    • “The once-daily oral medication is indicated in combination with other antihypertensive drugs to lower BP in adult patients who do not have their BP controlled with other therapies.
    • “It is believed that some people may respond better to the drug’s novel mechanism, as aprocitentan is a dual endothelin receptor antagonist that works differently than conventional diuretics, renin-angiotensin-aldosterone system antagonists, calcium channel blockers, and beta-blockers used to lower BP.”
  • Beckers Hospital Review considers the three generations of weight loss drugs.
    • “Anita Courcoulas, MD, defines GLP-1s as “generation one;” dual GLP-1 and GIPs as the second; and a triple threat of GLP-1, GIP and GCGRs as the third generation of weight loss drugs. 
    • “Dr. Courcoulas is chief of Pittsburgh-based UPMC’s minimally invasive bariatric and general surgery program. She told Becker’s the next class of anti-obesity medications are finally reaching weight loss outcomes seen from gastric sleeve and bypass procedures, the two most common surgeries for trimming pounds. * * *
    • “Dr. Courcoulas said the biggest unknown is long-term durability of these medications, a concern other bariatric experts have raised. 
    • “She expects GLP-GIP-GCGR medications to gain approval and enter the U.S. market next year. 
    • “I think it’s very exciting to realize there are medications that are under investigation now that could come to market that could have even better weight loss results than the two drug [classes] we’re seeing now,” Dr. Courcoulas said.”
  • The National Institutes of Health announced,
    • “SARS-CoV-2, the virus that causes COVID-19, can damage the heart even without directly infecting the heart tissue, a National Institutes of Health-supported study has found. The research, published in the journal Circulation, specifically looked at damage to the hearts of people with SARS-CoV2-associated acute respiratory distress syndrome (ARDS), a serious lung condition that can be fatal. But researchers said the findings could have relevance to organs beyond the heart and also to viruses other than SARS-CoV-2.
    • “Scientists have long known that COVID-19 increases the risk of heart attack, stroke, and Long COVID, and prior imaging research has shown that over 50% of people who get COVID-19 experience some inflammation or damage to the heart. What scientists did not know is whether the damage occurs because the virus infects the heart tissue itself, or because of systemic inflammation triggered by the body’s well-known immune response to the virus.
    • “This was a critical question and finding the answer opens up a whole new understanding of the link between this serious lung injury and the kind of inflammation that can lead to cardiovascular complications,” said Michelle Olive, Ph.D., associate director of the Basic and Early Translational Research Program at the National Heart, Lung, and Blood Institute (NHLBI), part of NIH. “The research also suggests that suppressing the inflammation through treatments might help minimize these complications.”
  • and
    • “An investigational gene therapy for a rare neurodegenerative disease that begins in early childhood, known as giant axonal neuropathy (GAN), was well tolerated and showed signs of therapeutic benefit in a clinical trial led by the National Institutes of Health (NIH). Currently, there is no treatment for GAN and the disease is usually fatal by 30 years of age. Fourteen children with GAN, ages 6 to 14 years, were treated with gene transfer therapy at the NIH Clinical Center and then followed for about six years to assess safety. Results of the early-stage clinical trial appear in the New England Journal of Medicine. 
    • “The gene therapy uses a modified virus to deliver functional copies of the defective GAN gene to nerve cells in the body. It is the first time a gene therapy has been administered directly into the spinal fluid, allowing it to target the motor and sensory neurons affected in GAN. At some dose levels, the treatment appeared to slow the rate of motor function decline. The findings also suggest regeneration of sensory nerves may be possible in some patients. The trial results are an early indication that the therapy may have favorable safety and tolerability and could help people with the rapidly progressive disease.
    • “One striking finding in the study was that the sensory nerves, which are affected earliest in GAN, started ‘waking up’ again in some of the patients,” said Carsten G. Bonnemann, M.D., senior author and chief of the Neuromuscular and Neurogenetic Disorders of Childhood Section at the National Institute of Neurological Disorders and Stroke (NINDS), part of NIH. “I think it marks the first time it has been shown that a sensory nerve affected in a genetic degenerative disease can actually be rescued with a gene therapy such as this.”
  • Lifesciences Intelligence reports,
    • “Recently, JAMA Network Open published a study analyzing the association between a healthy diet, sleep duration, and type 2 diabetes (T2D) risk. The study data revealed that habitual short sleep duration was linked to an increased probability of T2D by as much as 41%.
    • “Using data on 247,867 individuals from the UK biobank, researchers divided patients into groups based on their sleeping habits. The stratified groups included normal (7–8 hours per night), mildly short (6 hours per night), moderately short (5 hours per night), and extremely short (3–4 hours per night).
    • “Across all study participants, only 3.2% were diagnosed with T2D; however, the adjusted hazard ratios revealed that the prevalence of T2D was higher among shorter sleep groups. More specifically, the increased probability of T2D was identified in those who slept 5 hours or less per night. Those in the moderate short sleep group were 16% more likely to have a T2D diagnosis. Additionally, those in the extremely short sleep group had a 41% greater likelihood of being diagnosed with T2D.”

From the U.S. healthcare business front,

  • BioPharma Dive relates,
    • “Orchard Therapeutics said Wednesday it will offer a new gene therapy to children with a rare, devastating disease at a record-setting wholesale price of $4.25 million. 
    • “The therapy, Lenmeldy, won Food and Drug Administration approval on Monday to treat patients with early-onset metachromatic leukodystrophy, or MLD. The disease, which most often attacks infants between six months and two years of age, robs patients of the ability to walk, talk and function in the world, killing most of its earliest victims within five years of onset.
    • “Lenmeldy’s price tag will leapfrog those of the two most expensive gene therapies available in the U.S. Sarepta Therapeutics sells its Elevidys treatment for Duchenne muscular dystrophy for $3.2 million, while CSL and UniQure’s hemophilia treatment Hemgenix costs $3.5 million.”
  • MedPage Today lets us know,
    • “Despite being a growing percentage of the physician workforce, women physicians continued to be paid less than their male colleagues, a strong body of evidence shows.
    • “While the gender pay gap decreased by 2% from 2021 to 2022 — from 28% to 26% — the gap was still significant, according to online networking service Doximity’s 2023 physician compensation reportopens in a new tab or window.
    • “Women doctors in 2022 earned nearly $110,000 less per year than men physicians, on average, after adjusting for specialty, location, and years of experience. Data from individual states have backed up this figure, too. For instance, in 2022, the Maryland State Medical Society conducted a survey and found that women doctors in Maryland are paid about $100,000 less annually than men.”
  • Beckers Hospital Review lists ten common issues in pharmacies.
  • United Healthcare updated its Change Healthcare cyberattack response website today.
  • HR Daily Advisor explains how companies are exploring the limitations of employee assistance plans amid the country’s mental health crisis.
  • Forbes reports,
    • “Medical diagnosis and procedure codes are so numerous and varied that Debbie Beall, manager of coding at Houston Methodist in Texas, needs a 49-person team to translate the medical notes written by the system’s 1,600 clinicians into the codes needed to bill insurers.
    • “There is a medical code for every imaginable scenario – from “burn due to water-skis on fire” to “spacecraft collision injuring occupant” — and their specificity determines how much the insurance companies pay. Each team member processes anywhere from 70 to 250 claims per day, depending on the complexity, she said. That’s why Beall is so excited about the possibility of using artificial intelligence to speed up the job.
    • “There’s no way I’m ever going to replace coders completely with an AI system,” Beall told Forbes. But for run-of-the-mill procedures performed multiple times a day in a hospital, like X-rays and EKGs? “Yes, an AI engine can do that.”
    • “Beall was one of the first dozen or so people to test a prototype of an AI-powered medical coding tool from electronic health records giant Epic Systems, which had $4.6 billion in revenue in 2022. Based on GPT-4, the large language model that powers the viral chatbot ChatGPT, Epic’s coding assistant prototype ingests and summarizes clinician notes and then tees up the “most likely” diagnosis codes and procedures codes, along with suggestions of “other potential codes,” according to mock ups viewed by Forbes that did not include real patient information. * * *
    • “While Epic has so far focused on using generative AI in back office functions, it has also been working on a patient-facing application that wouldn’t require human review. Krause told Forbes a tool that would help explain the patient’s bill, including their deductible and outstanding balance, could be rolled out by November. “We feel like that’s a fairly benign place to start. It’s not about healthcare at that point, but it’s really about their billing,” he said. “That’s not going to harm a patient in any way.”

   

Tuesday Tidbits

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, Electronic health records, FDA, Generative AI, HIPAA Privacy and Security Rules, Medical / Rx research, Medicare, U.S. Healthcare–
Photo by Maddy Weiss on Unsplash

Happy First Day of Spring!

From Washington, DC,

  • The Wall Street Journal reports,
    • “Lawmakers who are finishing writing six annual spending bills have resolved a last-minute roadblock over border funding, setting the stage for Congress to review and approve the legislation on a tight timeline that could take them to the brink of a partial government shutdown this weekend. 
    • “Congressional negotiators late Monday reached a deal on the provisions within the Department of Homeland Security’s funding bill. That bill got caught in an 11th-hour tangle with the White House over border spending, which has become a top issue in many swing states during the 2024 presidential-election year.
    • “In a statement Tuesday morning, Speaker Mike Johnson (R., La.) said an agreement has been reached on the Homeland Security funds, and House and Senate committees have begun drafting bill text to be “prepared for release and consideration by the full House and Senate as soon as possible.”
    • “President Biden said Tuesday that a path on the remaining funding legislation had been finalized and he would sign the measure immediately when it gets to his desk.”
  • Per a House Budget Committee press release,
    • “Today, the House of Representatives advanced House Budget Committee legislation, H.R. 766, the Dr. Michael C. Burgess Preventative Health Savings Act (PHSA), to the Senate by a voice vote. 
    • “The historic accomplishment marks the first time in history that a bipartisan bill with sole Budget Committee jurisdiction has been brought to the Floor under a suspension of the House rules. * * *
    • “One of the major barriers to deploying modernized and innovative policies that would unequivocally curb the cost of health care is the antiquated process used for calculating congressional cost estimates on proposed health care legislation.
    • “Congressional scorekeepers have traditionally focused solely only on the short-term valuation of a policy rather than capturing the long-term economic impact.
    • “But today, with passage of H.R. 766, that changes. This bill seeks to improve the methodology of Congress’ broken budgetary process by providing policymakers with a more accurate cost estimate of the long-term cost savings from preventive health care policies.”
  • Per an HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), announced a new voluntary model that empowers primary care providers in eligible Accountable Care Organizations (ACOs) to treat people with Medicare using innovative, team-based, person-centered proactive care. A key part of the Biden-Harris Administration’s efforts to further promote competition in health care, the ACO Primary Care Flex Model (ACO PC Flex Model) will provide a one-time advanced shared savings payment and monthly prospective primary care payments (PPCPs) to ACOs. The advanced shared savings payments provide ACOs with needed resources and flexibility to cover costs associated with forming an ACO (where relevant) and administrative costs for required model activities. PPCPs will be distributed by ACOs to primary care practices, giving them improved resources and flexibility to provide care that best suits individuals’ needs.” * * *
    • “The ACO PC Flex Model is a five-year voluntary model that will begin on January 1, 2025. CMS is planning to select approximately 130 ACOs to participate in the model. Organizations interested in participating must first apply — either as new ACOs or renewing ACOs — to the Shared Savings Program. Shared Savings Program Applications are open May 20, 2024 – June 17, 2024. The ACO PC Flex Model Request for Applications (RFA) is planned to be released in the second quarter of 2024.
    • “For Frequently Asked Questions about the Primary Care Flex Model, please visit: https://www.cms.gov/priorities/innovation/innovation-models/aco-primary-care-flex-model/faqs.
    • “For a fact sheet on the model, please visit: https://www.cms.gov/files/document/aco-pc-flex-fs.pdf – PDF.”
  • Yesterday, HHS’s Office for Civil Rights offered guidance to HIPAA covered entities and business associates about their use of online tracking technologies.
    • “Compliance with the Security Rule helps lower the risk of unauthorized access to ePHI collected through a regulated entity’s website or mobile app that could lead to harm to individuals. Therefore, OCR is prioritizing compliance with the HIPAA Security Rule in investigations into the use of online tracking technologies. OCR’s principal interest in this area is ensuring that regulated entities have identified, assessed, and mitigated the risks to ePHI when using online tracking technologies and have implemented the Security Rule requirements to ensure the confidentiality, integrity, and availability of ePHI. OCR investigations are fact-specific and may involve the review of technical information regarding a regulated entity’s use of any tracking technologies. OCR considers all of the available evidence in determining compliance and remedies for potential noncompliance.”
  • The U.S. Preventive Services Task Force issued the following final recommendation today:
    • “For children and adolescents younger than 18 years without signs and symptoms of or known exposure to maltreatment: The evidence is insufficient to assess the balance of benefits and harms of primary care interventions to prevent child maltreatment. [Grade I]”
  • Beckers Payer Issues discusses what fifteen insurers and trade associations explored with Biden Administration officials yesterday about the Change Healthcare situation.
    • During the meeting, stakeholders discussed how progress has been made in reestablishing claims processing systems, though small, rural and safety-net providers specifically are still reporting issues with cash flow.
    • Many healthcare organizations will require third-party certification of Change’s cybersecurity before reconnecting to its systems, in which UnitedHealth was urged to provide a timeframe around. Payers were also asked to analyze their internal data to determine which providers need more support and to engage with them directly.
    • According to Reuters, payers said they would accelerate payments to Medicare and Medicaid providers, along with providing loans to Medicaid providers.”
  • Here is a link to the HHS readout from this meeting.
  • The U.S. Postal Service reminded its retirees with Part A only about the opportunity to enroll for Medicare Part B with no late enrollment penalty during a special enrollment period beginning April 1, 2024. The Postal Service is picking up the late enrollment penalty cost. This is a good deal.
    • “The one-time PSHB SEP is from April 1, 2024, to Sept. 30, 2024. Individuals eligible for the PSHB SEP will receive notification by U.S. Mail™ in March 2024.
    • “All required information must be returned in the envelope provided and postmarked by Sept. 30, 2024.”
  • The Food and Drug Administration announced,
    • “On Monday, the FDA launched a new portal for patients, consumers and health care professionals to report potential drug shortage issues directly into CDER’s NextGen system without creating a NextGen account. 
    • “Since 2017, NextGen has been a way for regulated industry to communicate with the FDA, including submitting information on shortages, discontinuations, and anticipated supply disruptions. Non-industry stakeholders without a NextGen account previously reported information about potential shortages to the FDA’s Drug Shortages Staff by email. The new public portal allows anyone to submit shortage information through an online form directly into NextGen.  
    • “Expanding access to NextGen’s shortage reporting beyond regulated industry will allow for greater consistency and ease of reporting by outside stakeholders, and greater efficiency in tracking and responding to these reports.” 

From the public health and medical research front,

  • MedPage Today informs us,
    • “Investigation of an early signal for stroke associated with COVID-19 bivalent vaccines turned into suspicion of high-dose or adjuvanted flu shots instead, based on a large U.S. population-based study.
    • “When researchers inspected a large Medicare database, they found no evidence of a significantly elevated risk for stroke at 1-21 days or 22-42 days after vaccination with either of the mRNA COVID vaccines distributed for the 2022-2023 respiratory season when compared with the 43-90 day control window, reported researchers led by Yun Lu, PhD, a statistician of the FDA in Silver Spring, Maryland.
    • “There was a significant excess of nonhemorrhagic stroke for people with concomitant administration of Pfizer-BioNTech’s bivalent vaccine plus a high-dose or adjuvanted influenza vaccine during the 22-42 days risk window (risk difference of 3.13 out of 100,000 doses); and a significant excess of transient ischemic attack for people with concomitant administration of Moderna’s bivalent COVID vaccine plus a high-dose or adjuvanted influenza vaccine during the 1-21 days risk window (risk difference of 3.33 out of 100,000 doses).
    • “But the researchers found that people with administration of a high-dose or adjuvanted influenza vaccine alone (without concomitant COVID vaccination) had an elevated risk for the combined outcome of nonhemorrhagic stroke or transient ischemic attack in both the 1-21 days risk window (risk difference of 1.65 per 100,000 doses) and 22-42 days risk window (risk difference of 1.60 per 100,000 doses).
    • “This finding suggests that the observed association between vaccination and stroke in the concomitant subgroup was likely driven by a high-dose or adjuvanted influenza vaccination,” the investigators reported in JAMA.”
  • Medscape lets us know,
    • “The US Food and Drug Administration (FDA) has cleared the twiist automated insulin delivery (AID) system (Sequel Med Tech, LLC; Manchester, NH) for people aged 6 years or older with type 1 diabetes. 
    • “The system comprises a novel insulin pump developed by Sequel’s research and development partner DEKA and uses the FDA-cleared Tidepool Loop algorithmthat was originally developed through patient-led, open-source initiatives.
    • “The twiist AID system has the capacity to work interchangeably with different integrated continuous glucose monitors (iCGMs), and Sequel will announce their initial iCGM partner closer to market launch, Sequel CEO and co-founder Alan Lotvin, MD, told Medscape Medical News. 
    • “It is the first AID system that directly measures volume and flow of insulin delivery, which enables it to rapidly detect obstructions or occlusions, usually within about 20 minutes, Lotvin explained. “

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Elevance Health has inked a deal to acquire Kroger Specialty Pharmacy.
    • “The grocery chain announced Monday that an agreement is in place, saying it’s expected to close in the back half of 2024 pending regulatory approvals. Elevance intends to add Kroger Specialty Pharmacy to its CarelonRx business, which houses its pharmacy benefit management services.
    • “Financial terms of the sale were not disclosed.”
  • Per BioPharma Dive,
    • “AstraZeneca is the latest large pharmaceutical company to make a sizable bet on radiopharmaceutical drugs for cancer, agreeing on Tuesday to acquire longtime biotechnology partner Fusion Pharmaceuticals in a deal worth up to $2.4 billion.
    • “AstraZeneca will acquire all of Fusion’s shares for $21 apiece, or about $2 billion. The British drugmaker could add another $3 per share via a financial instrument known as a “contingent value right” if Fusion meets an unspecified regulatory milestone. Should Fusion hit that mark, the buyout would be worth $2.4 billion.” 
  • Beckers Health IT offers six takeaways from last month’s HIMSS conference.

Monday Roundup

David Ermer–CDC, Congress, COVID-19 vaccine, FDA, Medical / Rx research, NIH, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • Roll Call reports,
    • “Lawmakers are back to writing a full-year fiscal 2024 Homeland Security appropriations bill in a dramatic, last-minute shift following White House intervention over the weekend, sources familiar with the decision said Sunday night. 
    • “Appropriators had been working on a yearlong stopgap measure, negotiating necessary changes to the fiscal 2023 status quo to be included as “anomalies,” after talks on a full-year bill initially fell apart late last week. * * *
    • “While the situation remains fluid, the move back toward a full-fledged bill is ultimately a sign of forward momentum. However, release of text for the complete six-bill package is now expected Monday at the earliest, putting Congress on a compressed timeline to clear the legislation before Friday at midnight, when current stopgap funding lapses.
    • “House rules allot members 72 hours to read legislation before voting on it, and it usually takes the Senate a couple days to process any legislation. The package will also include the Defense, Labor-HHS-Education, Financial Services, Legislative Branch and State-Foreign Operations measures.” 
  • The White House issued an Executive Order on Advancing Women’s Health Research and Innovation. Here is a link to the White House fact sheet.
    • “Today, President Biden is signing a new Executive Order that will direct the most comprehensive set of executive actions ever taken to expand and improve research on women’s health. These directives will ensure women’s health is integrated and prioritized across the federal research portfolio and budget, and will galvanize new research on a wide range of topics, including women’s midlife health.”
  • The White House also announced,
    • “President Biden’s Cancer Moonshot is accelerating progress to prevent, detect, and treat cancer while boosting support for families facing cancer, including by undertaking an aggressive effort to protect families and workers from hazardous chemicals like known carcinogens. After more than three decades of inadequate protections, today the Environmental Protection Agency (EPA) is announcing a historic ban on ongoing uses of asbestos. This marks the first rule finalized under the nation’s updated chemical safety law, a milestone in the Biden-Harris Administration’s efforts to protect public health, advance environmental justice, and end cancer as we know it.”

From the Food and Drug Administration front,

  • The FDA informed us,
    • “Today, the U.S. Food and Drug Administration approved Lenmeldy (atidarsagene autotemcel), the first FDA-approved gene therapy indicated for the treatment of children with pre-symptomatic late infantile, pre-symptomatic early juvenile or early symptomatic early juvenile metachromatic leukodystrophy (MLD). 
    • “Metachromatic leukodystrophy is a debilitating, rare genetic disease affecting the brain and nervous system. It is caused by a deficiency of an enzyme called arylsulfatase A (ARSA), leading to a buildup of sulfatides (fatty substances) in the cells. This buildup causes damage to the central and peripheral nervous system, manifesting with loss of motor and cognitive function and early death. It is estimated that MLD affects one in every 40,000 individuals in the United States. There is no cure for MLD, and treatment typically focuses on supportive care and symptom management.”
  • MPR reports,
    • “The Food and Drug Administration (FDA) has approved Xhance® (fluticasone propionate) nasal spray for the treatment of chronic rhinosinusitis without nasal polyps in patients 18 years of age and older. Previously, the treatment was only approved for adults with nasal polyps.
    • “Xhance is a drug-device combination therapy that delivers fluticasone, a corticosteroid, deep into difficult-to-access sinuses and sinonasal drainage tracts. The medication is delivered into the nose by actuating the pump spray into 1 nostril while simultaneously blowing (exhaling) into the mouthpiece of the device.”

From the public health and medical research front,

  • MedPage tells us,
    • “Preventing SARS-CoV-2 infection in immunocompromised people hasn’t gotten any easier as the pandemic trundles on into its fifth year. * * *
    • “Vaccination against SARS-CoV-2 is now the key prevention strategy for this vulnerable population, and people who are immunocompromised should still get COVID boosters — but, given that they are less likely to generate an adequate immune response to the vaccines, the question is: how often? * * *
    • “Of three clinicians who treat moderately to severely immunocompromised patients and spoke with MedPage Today, all of them offered a similar recommendation: people who are immunocompromised should get a COVID vaccine about every 6 months, with the caveat that intervals between vaccine doses should be tailored to individual patient needs.”
  • and
    • “Electronic nudges sent to patients failed to increase influenza vaccine uptake in one randomized clinical trial, while another trial found that slight increases in vaccination rates from letters emailed to patients failed to impact clinical outcomes.
    • “Neither portal nor text messages to remind patients to get an influenza vaccination were effective at a population level at improving vaccination uptake, Peter Szilagyi, MD, MPH, of the UCLA Mattel Children’s Hospital at the University of California in Los Angeles, and colleagues reported in JAMA Internal Medicine. Among patients who received care from 79 primary care practices in a large healthcare system, flu shot rates remained at approximately 47% whether patients received portal messages, text messages, or no reminders at all.
    • “And in an analysis of the Danish NUDGE-FLU trial, an about 1% boost in influenza vaccination associated with email letters encouraging patients to get vaccinated did not translate into improvements in cardiovascular, respiratory, or other clinical endpoints, Niklas Johansen, MD, of the Copenhagen University Hospital-Harlev and Gentofte in Denmark, and colleagues wrote in the Annals of Internal Medicine“
  • Healio lets us know,
    • “A CDC program to distribute free HIV self-test kits has mailed nearly double the number of tests in its first year than expected.
    • “More than one-quarter of people receiving tests had never tested for HIV before.”
  • The National Institutes of Health announced,
    • “Using advanced imaging techniques and in-depth clinical assessments, a research team at the National Institutes of Health (NIH) found no significant evidence of MRI-detectable brain injury, nor differences in most clinical measures compared to controls, among a group of federal employees who experienced anomalous health incidents (AHIs). These incidents, including hearing noise and experiencing head pressure followed by headache, dizziness, cognitive dysfunction and other symptoms, have been described in the news media as “Havana Syndrome” since U.S. government personnel stationed in Havana first reported the incidents. Scientists at the NIH Clinical Center conducted the research over the course of nearly five years and published their findings in two papers in JAMA today.
    • “Our goal was to conduct thorough, objective and reproducible evaluations to see if we could identify structural brain or biological differences in people who reported AHIs,” said Leighton Chan, M.D., chief, rehabilitation medicine and acting chief scientific officer, NIH Clinical Center, and lead author on one of the papers. “While we did not identify significant differences in participants with AHIs, it’s important to acknowledge that these symptoms are very real, cause significant disruption in the lives of those affected and can be quite prolonged, disabling and difficult to treat.”
  • and
    • “Fenoprofen, a nonsteroidal anti-inflammatory drug (NSAID), successfully alleviated pain and inflammation in a rodent model of endometriosis, according to researchers funded by the National Institutes of Health (NIH). They chose the drug after using a computer algorithm to evaluate nearly 1,300 existing compounds for their ability to reverse gene expression related to endometriosis disease. The study was funded by NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
    • “Analysis by researchers at the University of California, San Francisco, using publicly available data from people with endometriosis, returned 299 candidate compounds with seven considered top candidates. These drugs included commonly used treatments for the disease, such as aspirin, as well as those not yet studied for this purpose. The researchers chose fenoprofen for further evaluation because it returned the highest gene expression reversal score and belongs to a drug class—NSAIDS—that is one of the first-line treatments for endometriosis.
    • “Fenoprofen is a prescription drug approved for the relief of mild to moderate pain and is often prescribed for arthritis. The researchers analyzed electronic medical records from five University of California healthcare institutions and found that the drug had been prescribed for less than 1% of patients with endometriosis or related conditions. They then tested fenoprofen in a rodent model of the disease, observing that it successfully alleviated vaginal hyperalgesia, a surrogate marker for endometriosis-related pain.
    • “If future studies in people confirm these findings, the researchers suggest that fenoprofen could be prescribed more frequently to treat endometriosis pain. Their work also supports continued use of their computer-based approach to repurpose other existing drugs as potential therapeutic candidates for endometriosis.”

From the U.S. healthcare business front,

  • Beckers Hospital Review updates us on the Change Healthcare situation. UHC updated its Change Healthcare cyberattack response website today.
  • The Washington Post considers whether the millions of dollars that Medicare pays for remote vital signs monitoring is worthwhile.
    • “While some small studies show remote monitoring can improve patient outcomes, researchers say it is unclear which patients are helped most and how long they need to be monitored.
    • “The research evidence is not as robust as we would like to show that it is beneficial,” said Ateev Mehrotra, a Harvard Medical School researcher.
    • “A January report by the Bipartisan Policy Center, a D.C. think tank, warned about “a lack of robust evidence on the optimal use of remote monitoring” and said some policy and medical experts “question whether we are effectively ‘rightsizing’ the use of these services, ensuring access for patients who need it most, and spending health care dollars in effective ways.”
  • Beckers Hospital Review lets us know the fifteen best and worst states for doctors.
    • “Montana, South Dakota and Nebraska are the top three states for physicians to practice in the U.S., according to WalletHub’s 2024 ranking published March 18. Hawaii, Rhode Island and New Jersey were deemed the worst.
    • “The annual ranking is based on two key dimensions: opportunity and competition, and medical environment.”
  • Per Fierce Healthcare,
    • “Highmark Health recorded $27.1 billion in revenue and a net income of $533 million for 2023, the company announced during its fourth-quarter results Monday.
    • “The company reported an operating margin of $338 million, though there was an operating loss of of $117 million during 2023 for the Allegheny Health Network as the system recovers from the pandemic. That was offset by gains seen in health insurance and other investments.
    • “According to a press release, Highmark holds $11 billion in cash and investments, and Highmark Health Plans reported an operating gain of approximately $400 million in 2023. It remains the largest insurer in Pennsylvania, Delaware, Virginia and western New York, said CEO David Holmberg. It was also selected to provide Medicaid to eligible members in West Virginia.
    • “He said Highmark’s annual revenue has grown 72% and Highmark Health Plan’s membership has grown 32% since 2013.
    • “We have transformed from a successful regional insurer into an innovative, diversified health organization, comprehensive solutions and national influence,” he said.”
  • The Washington Post relates,
    • “AstraZeneca is capping out-of-pocket costs for inhalers and related medication at no more than $35 per month, the drugmaker announced Monday.
    • “The Britain based pharma giant said the expanded savings are intended to help vulnerable patients with asthma or chronic obstructive pulmonary disease, especially those without health insurance. The price cap takes effect June 1.”
  • Beckers Hospital Review adds,
    • “First-time prescriptions for Eli Lilly’s Zepbound surpassed those for Novo Nordisk’s Wegovy in early March, according to data cited by Reuters. 
    • “For the week ending March 8, 77,590 new prescriptions were filled for Zepbound and about 71,000 were filled for Wegovy. It’s the first time Zepbound, a chronic weight management therapy approved in early November and released in December, eclipsed Novo Nordisk’s blockbuster weight loss drug.” 

Happy Pi Day!

David Ermer–CDC, Congress, FDA, HSA, Medical / Rx research, Medicare, Rx coverage–
Photo by Taso Katsionis on Unsplash

From Washington, DC

  • The bipartisan leadership of the Senate Finance Committee are pressing Congress for prescription benefit manager reform.
    • Senate Finance Committee Chair Ron Wyden, D-Ore., and Ranking Member Mike Crapo R-Idaho, today renewed their call for the passage of their bipartisan legislation to crack down on pharmacy benefit managers (PBMs) and their shadowy tactics that are driving up the cost of prescription drugs and forcing pharmacies across the country to close their doors.
    • Ahead of a press conference this morning where Senators Wyden and Crapo were joined by pharmacy and patient advocates to press for PBM reform, the Senators sent a letter to their Finance Committee colleagues reaffirming their commitment to getting their legislation across the finish line as soon as possible this Congress.
  • FEHBlog observation — Read this Brookings Institution article to understand why the Senator’s position may be overwrought.
  • STAT News reports,
    • “Novo Nordisk’s newly won permission to market the heart benefits of its obesity drug Wegovy could provide a backdoor way to expand access to the drug for people on Medicare, experts told STAT.
    • “Currently, Medicare is prohibited by law from covering medications for obesity treatment alone. While companies that manufacture wildly popular anti-obesity medications and their allies haven’t been successful in lobbying Congress to change the law, the Food and Drug Administration’s move could give doctors an avenue to prescribe the medications to some Medicare patients.
    • “Wegovy’s new label indicates that the drug can be used to reduce the risk of major heart complications for people who are overweight or obese and have existing heart disease, Novo said in a statement Friday.
    • “This is definitely… an opportunity for patients with both cardiovascular disease and obesity to potentially get this drug when they couldn’t get it just for obesity alone,” said Juliette Cubanski, deputy director of the Program on Medicare Policy at KFF.”
  • MedPage Today tells us,
    • “The FDA granted accelerated approval to resmetirom (Rezdiffra) as the first treatment for adults with noncirrhotic non-alcoholic steatohepatitis (NASH), also now referred to as metabolic dysfunction-associated steatohepatitis (MASH).
    • “A once-daily oral agent, resmetirom is a liver-directed thyroid hormone receptor (THR)-β selective agonist designed to target key underlying causes of NASH; the drug is specifically indicated for NASH patients with moderate to advanced liver fibrosis, consistent with stages F2 to F3 fibrosis, and should be used along with diet and exercise, according to the agency.
    • “Previously, patients with NASH who also have notable liver scarring did not have a medication that could directly address their liver damage,” said Nikolay Nikolov, MD, of FDA’s Center for Drug Evaluation and Research, in a statement. “Today’s approval of Rezdiffra will, for the first time, provide a treatment option for these patients, in addition to diet and exercise.”
    • “A result of non-alcoholic fatty liver disease (NAFLD) progression, NASH can lead to liver fibrosis and dysfunction, raising the risk of transplant and hepatocellular carcinoma. The condition is often associated with hypertension and diabetes.
    • “According to some estimates, 6 million or more Americans have NASH with stages F2 to F3 fibrosis, a number only expected to increase in the coming years.”
  • Healthcare IT News fills us in on an interesting conversation between the Deputy Coordinator of Health Information Technology and the CDC Director at the HIMSS conference in Orlando.

From the public health and medical research front,

  • The New York Times reports,
    • “Teen pregnancy increases the chances that a young woman will drop out of school and struggle with poverty, research has shown. Teenagers are also more likely to develop serious medical complications during pregnancy.
    • “Now a large study in Canada reports another disturbing finding: Women who were pregnant as teenagers are more likely to diebefore their 31st birthday. The trend was observed among women who had carried teen pregnancies to term, as well as among those who had miscarried.
    • “The younger the person was when they became pregnant, the greater their risk was of premature death,” said Dr. Joel G. Ray, an obstetric medicine specialist and epidemiologist at St. Michael’s Hospital in Toronto and the first author of the study. It was published in JAMA Network Open on Thursday.
    • “Some people will argue that we shouldn’t be judgmental about this, but I think we’ve always known intuitively that there’s an age that is too young for pregnancy,” he added.
  • The Washington Posts informs us,
    • “A new study calls into question the extent of the maternal mortality crisis in the United States, which has long posted a disproportionately high rate of maternal deaths compared with peer nations.
    • “Data classification errors have inflated U.S. maternal death rates for two decades, according to the study published Wednesday in the American Journal of Obstetrics & Gynecology. Instead of the maternal death rate more than doubling since 2002, it has remained flat, researchers found.
    • “There has been a lot of alarm and apprehension surrounding the fact that some of these reports show a threefold increase in maternal mortality, and that is not what we found. We found low and stable rates,” said K.S. Joseph, the study’s lead author and professor in the departments of obstetrics and gynecology and the School of Population and Public Health at the University of British Columbia in Vancouver. * * *
    • “Some experts say the study’s biggest takeaway is the persistent racial disparities, with many pregnant Black people experiencing more medical complications involving Caesarean sections, postpartum hemorrhaging and preterm births. However the data is calculated, the pattern remains the same, said Colleen Denny, an associate professor in the department of obstetrics and gynecology and director of family planning at NYU Langone Hospital as well as a fellow of the American College of Obstetricians and Gynecologists.
    • “We should be targeting a lot of our public outreach to focus on conditions that are affecting patients of color while they’re pregnant,” said Denny, who was not involved with the study.”

From the cybersecurity front,

  • UHC updated its Change Healthcare cyberattack response website today.
    • “Palo Alto Networks Unit 42 experts are on the ground, collaborating diligently with UnitedHealth and their partners to restore operations and ensure a swift and secure resolution following the recent disruption. To date we have reviewed and protected a large majority of infrastructure, including the server and application space, and assisted in bringing critical services back online that allowed for more than 9 million prescriptions to be filled.” 
  • The American Hospital Association News lets us know,
    • “The Centers for Medicare & Medicaid Services March 13 released additional information on the Medicare accelerated and advance payments that hospitals, physicians and others impacted by the Change Healthcare cyberattack may apply for through their Medicare Administrative Contractors. According to CMS, the MACs aim to review requests and notify most providers/suppliers of the outcome of their request within five business days of receipt.
  • Aetna provides a good example of the information that other carriers are sharing with their network providers and members about the Change Healthcare situation.

From the U.S. healthcare business front,

  • EBRI offers new research about health savings accounts.
    • “HSA balances continued to increase over the course of the year, despite higher spending on health care. Continuing a trend observed post-COVID-19 pandemic, patient spending on health care increased in 2022. Still, average end-of-year HSA balances were higher than average beginning-of-year balances. Average balances increased at an even faster rate in 2022, conditional on those accounts receiving either an employee or employer contribution over the course of the year. 
    • “Accounts that received an employer contribution saw higher total contributions and were more likely to invest. Employers seeking to help their workers engage with their HSAs may find employer contributions to be a useful tool, as accountholders who received an employer contribution on their behalf had higher average total contributions and were more likely to invest. Our analysis indicates, however, that these accountholders were also more likely to take more frequent and larger distributions. 
    • “Most accountholders took a distribution in 2022. More than half of the HSAs in EBRI’s database saw a distribution in 2022, and the average distribution was $1,868. 
    • “Relatively few HSAs are invested. One of the largest advantages HSAs offer is the ability to invest assets within the account. However, our analysis reveals that only 13% of accountholders invested their HSAs in assets other than cash. 
    • “Age and tenure play a major role in HSA utilization. Consistent with previous findings, accountholder age — as well as accountholder tenure — is closely related to average balances, contributions, and distributions, as well as the propensity to invest. On average, older accountholders contributed more to their HSAs, had higher balances, more frequently took distributions, and had a higher likelihood of investing at least some portion of their HSA in assets other than cash.”
  • McKinsey and Co. shares its report on the future of Medicare Advantage.
    • “The Medicare Advantage program is undergoing its biggest shifts in more than two decades. Payers can take steps now to mount a strategic, agile response as the changes unfold.”